BioMerieux Recalls

377 recalls on record in the United States

medical: 377
medical Class II
2017-12-27

BioMerieux SA recalls ETEST OXACILLIN OX 256 US F100 In vitro diagnostic, a

QC failures (MIC out of range high) for S.aureus ATCC 29213 strain on ETEST OX 256 (OXACILLIN) Foam packaging (Ref. 520558, 520518) reported. The product behavior could lead to False Resistant results.

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medical Class II
2017-12-27

BioMerieux SA recalls ETEST OXACILLIN OX 256 WW F100 In vitro diagnostic, a q

QC failures (MIC out of range high) for S.aureus ATCC 29213 strain on ETEST OX 256 (OXACILLIN) Foam packaging (Ref. 520558, 520518) reported. The product behavior could lead to False Resistant results.

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medical Class II
2017-11-15

BioMerieux SA recalls NucliSENS Lysis Buffer Extended lot for RES 76675

Elute may become colored due to the residual presence of heme group origination from hemoglobin present in whole blood samples as well as dried spot (DBS) samples. This can potentially cause the inhibition of PCR reactions and result in an uninterpretable test result. If using an Internal Control (IC) in the extraction process the IC could potentially be inhibited as well and invalidate test results.

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medical Class II
2017-11-15

Biomerieux Inc recalls VITEK2 GP-ID, REF 21342 IVD

Customers have reported, and an internal investigation has confirmed, occurrences of atypical negative O129R reactions for Enterococcus casseliflavus ATCC)R) 700327(TM) in association with three (3) VITEK(R) 2 GP ID Lots, causing failure of the Quality Control (QC) testing for the VITEK(R) 2 GP ID card. In accordance with the VITEK(R) 2 GP ID Instructions For Use, the expected O129R reaction for ATCC(R) 700327(TM) strain is positive. As a precaution, bioM¿rieux is also including in the scope of this notice all GP ID card lots manufactured with the same raw materials.

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medical Class II
2017-09-27

Biomerieux Inc recalls VITEK(R) 2 GP, REF 21342, IVD, UDI 03573026131920, bioMerieu

Customer reports have indicated occurrences of atypical negative O129R reactions for Enterococcus casseliflavus ATCC(R) 700327(TM) in association with VITEK(R) 2 GP ID Lot 2420240403 and 2420303403, causing failure of the Quality Control (QC) testing for the VITEK(R) 2 GP ID card. The expected O129R reaction for ATCC¿ 700327(TM) strain is positive.

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medical Class II
2017-09-20

bioMerieux, Inc. recalls eMAG System, Ref 418591 It is an In Vitro Diagnostic Medi

Some anomalies have been identified during manufacturing controls.

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medical Class II
2017-09-06

Biomerieux Inc recalls VITEK¿ 2 Compact 30, REF numbers: 27530 and 27530R (clinica

Customers have reported that some VITEK¿ 2 cards are staying in preliminary status, not finalizing after ejection from the instrument, and not allowing cards in subsequent carousel slots to be processed. The issue was reported to occur on VITEK¿ 2 Compact 15 and Compact 30 systems following a system software update to version 8.01.

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medical Class II
2017-09-06

Biomerieux Inc recalls VITEK¿ 2 Compact 15, REF numbers: 27415 and 27415R software

Customers have reported that some VITEK¿ 2 cards are staying in preliminary status, not finalizing after ejection from the instrument, and not allowing cards in subsequent carousel slots to be processed. The issue was reported to occur on VITEK¿ 2 Compact 15 and Compact 30 systems following a system software update to version 8.01.

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medical Class II
2017-08-02

Biomerieux Inc recalls VITEK 2 Gram Negative test kits containing colistin (cs01n)

The investigation demonstrated a high rate of very major errors (resistant isolates calling susceptible) with the VITEK¿ 2 AST-GN colistin (cs01n) compared to agar dilution (the reference method used for cs01n development) and compared to broth-microdilution (recommended method by EUCAST/CLSI).

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medical Class II
2017-07-19

bioMerieux, Inc. recalls VIDAS Testosterone, Ref 30418

Complaints were received from customers observing falsely overestimate results or external quality control higher results than expected when performing tests with VIDAS Testosterone.

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medical Class II
2017-06-21

Biomerieux Inc recalls VITEK¿ 2 Gram Negative Susceptibility card (AST-N351), IVD,

The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).

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medical Class II
2017-06-21

Biomerieux Inc recalls VITEK¿ 2 Gram Positive Susceptibility card (AST-P648), IVD,

The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).

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medical Class II
2017-06-21

Biomerieux Inc recalls VITEK¿ 2 Gram Positive Susceptibility card (AST-P580), REF 2

The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).

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medical Class II
2017-06-21

Biomerieux Inc recalls VITEK¿ 2 Gram Negative Susceptibility card (AST-GN80), REF 4

The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).

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medical Class II
2017-06-21

Biomerieux Inc recalls VITEK¿ 2 Gram Negative Susceptibility card (AST-N268), REF 4

The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).

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medical Class II
2017-06-21

Biomerieux Inc recalls VITEK¿ 2 Gram Negative Susceptibility card (AST-N300), IVD,

The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).

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medical Class II
2017-06-21

Biomerieux Inc recalls VITEK¿ 2 Gram Positive Susceptibility card (AST-P607), REF 2

The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).

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medical Class II
2017-06-21

Biomerieux Inc recalls VITEK¿ 2 Gram Negative Susceptibility card (AST-N222), REF 4

The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).

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medical Class II
2017-06-21

Biomerieux Inc recalls VITEK¿ 2 Gram Negative Susceptibility card (AST-N214), REF 4

The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).

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medical Class II
2017-06-21

Biomerieux Inc recalls VITEK¿ 2 Gram Negative Susceptibility card (AST-N362), IVD,

The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).

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medical Class II
2017-06-21

Biomerieux Inc recalls VITEK¿ 2 Gram Negative Susceptibility card (AST-N265), REF 4

The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).

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medical Class II
2017-06-21

Biomerieux Inc recalls VITEK¿ 2 Gram Streptococcus Susceptibility card (AST-ST01),

The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).

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medical Class II
2017-06-21

Biomerieux Inc recalls VITEK¿ 2 Gram Positive Susceptibility card (AST-P631), REF 4

The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).

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medical Class II
2017-06-21

Biomerieux Inc recalls VITEK¿ 2 Gram Negative Susceptibility card (AST-N359), IVD,

The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).

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medical Class II
2017-06-21

Biomerieux Inc recalls VITEK¿ 2 Gram Positive Susceptibility card (AST-GP67), REF 2

The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).

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medical Class II
2017-06-21

Biomerieux Inc recalls VITEK 2 Bacillus identification card (BCL), IVD, REF 21345,

The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).

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medical Class II
2017-06-21

Biomerieux Inc recalls VITEK¿ 2 Gram Negative Susceptibility card (AST-N212), REF 4

The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).

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medical Class II
2017-06-21

Biomerieux Inc recalls VITEK¿ 2 Gram Fungal Susceptibility card (AST-YS05), REF 41

The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).

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medical Class II
2017-06-21

Biomerieux Inc recalls VITEK¿ 2 Gram Positive Susceptibility card (AST-P600), REF 2

The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).

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medical Class II
2017-06-21

Biomerieux Inc recalls VITEK¿ 2 Gram Positive Susceptibility card (AST-P586), REF 2

The integrity of the product container may be compromised thereby exposing product to moisture which could lead to antibiotic degradation (loss of potency).

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Showing 30 of 377 recalls. See all →