Shellfish Recalls in the United States

Brahms GmbH recalls B.R.A.H.M.S PlGF Plus KRYPTOR, Catalog Number: 859075N. in

Customers have observed quality control values out of range at the lowest quality control level (QC Level 1) for the PIGF assay which require troubleshooting steps to resolve. If Quality Controls are not performed according to the Instructions for Use, the underestimation of QC1 may go undetected and could contribute to falsely elevated sFlt-1/PlGF ratio results. A falsely elevated sFlt-1/PlGF ratio may result in a higher-risk classification for progression to preeclampsia with severe features potentially leading to intensified clinical monitoring.

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F&S Fresh Foods, Inc. recalls ReadyMeals Turkey Bacon & Cheddar Pretzel Duo Sandwich, peri

Undeclared sesame. Sandwich contains visible sesame but label does not declare sesame.

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Connecticut Crab Company LLC recalls Crab Cakes various sizes sold to food service

May be temperature abused, which may result in growth of Clostridium botulinum

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Ajinomoto Foods North America Inc. recalls Item 81146 Ajinomoto Tai Pei Shrimp Fried Rice - Shrimp, veg

Foreign objects are glass varying in size from 1-3cm long and 2-4mm wide.

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ICU Medical, Inc. recalls Product Description/Item: ChemoLock Vial Spike, 20mm/011-CL-

Ports have a potential for unintended disconnection, inability to connect to or fully engage with injectors, due to a variation in the spring inside the Port, which may cause delay of therapy and exposure to caustic substances. Ports available as standalone connectors, or utilized as access points on vial adaptors, bag spikes, and administration sets.

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ICU Medical, Inc. recalls Product Description/Item: ChemoLock Bag Spike, 10 units/CL-1

Ports have a potential for unintended disconnection, inability to connect to or fully engage with injectors, due to a variation in the spring inside the Port, which may cause delay of therapy and exposure to caustic substances. Ports available as standalone connectors, or utilized as access points on vial adaptors, bag spikes, and administration sets.

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ICU Medical, Inc. recalls 8.5" (22 cm) Appx 0.85 ml, Bifuse Pressure Infusion (400 psi

Due to a manufacturing defect which results in a visible gap between the connector's top and bottom housing.

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ICU Medical, Inc. recalls 6" (15 cm) Appx 0.85 ml, Smallbore Trifuse Ext Set w/3 Micro

Due to a manufacturing defect which results in a visible gap between the connector's top and bottom housing.

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Associates of Cape Cod, Inc. recalls Fungitell STAT- IVD Assay for (1 ¿ 3)-~-D-Glucan in Serum R

Incorrect information on the Fungitell STAT clamshells containing the Fungitell STAT Standard, relates to printed information for reconstitution and pretreatment volumes

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Baxter Healthcare Corporation recalls Beach Chair Clamp, BEACH CHAIR SHLDER POSITIONER CMPT, REF A

the adhesive, applied to screws and bolts as an additional holding force, may not cure correctly, and as a result, could result in a loss of holding and reduced mechanical integrity.

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Baxter Healthcare Corporation recalls Simple Clamp, US/EURO Rails, UPPER EXTREMITY DISTRACTION CMP

the adhesive, applied to screws and bolts as an additional holding force, may not cure correctly, and as a result, could result in a loss of holding and reduced mechanical integrity.

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Abbott Molecular, Inc. recalls Abbott Alinity m System, REF 08N53-002, containing Amplifica

The instrument was found to be installed without plunger assemblies in the clamp bar for an Amplification Detection Unit. After correction of the issue, the instrument was returned for use without calibration. This would result in a potential for delay of results and incorrect results.

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MEDLINE INDUSTRIES, LP - Northfield recalls Centurion CirClamp with 1.3cm Bell & Insert Reprocessed, Reo

The CirClamp subassembly found in the kit was the incorrect size.

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MEDLINE INDUSTRIES, LP - Northfield recalls Centurion manual surgical kits labeled as: a) STERILE TUBE

Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users.

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