medical Class II Updated 2020-01-01

Ortho Clinical Diagnostics Inc recalls 7% BSA (Bovine Serum Albumin), Product Code: 8262487 - Produ

Recalled Product

7% BSA (Bovine Serum Albumin), Product Code: 8262487 - Product Usage: is used to dilute samples when assay values exceed the reportable (dynamic) range using the VITROS 250/350/5,1 FS/4600 Chemistry Systems and VITROS 5600/XT 7600 Integrated Systems.


Hazard / Issue

Potential for the instability of the diluents VITROS 7% BSA (Product Code 8262487) and VITROS Urine Electrolyte Diluent (UED) (Product Code 1110352) when stored in a 2mL cup for 7 days

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot with Expiry Date: D6289 2019-11-20 E6382 2020-01-15 F6602 2020-05-02 G6679 2020-08-13 H6897 2020-10-01 J7129 2021-01-23 K7421 2021-07-01 L7592 2021-08-26
View official government recall

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