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U.S. Department of Health and Human Services

Medical Device Recalls

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Total B-hCG Speciment Diluent is composed of 1 bottle of Total B-hCG Specimen Diluent containing ani... 2 07/12/2007 FEI # 2623532
Abbott Diagnostic International, Ltd.
IMx Theophylline Reagent Pack (List 1A81-20) In Vitro test. This reagent system is composed of one ... 2 07/03/2007 FEI # 2623532
Abbott Diagnostic International, Ltd.
Abbott AxSYM Matrix Cells--Product List No: 8A73-02, sold in boxes of 100 2 11/17/2006 FEI # 2623532
Abbott Diagnostic International, Ltd.
FSH Calibrators (LN 9C06-01), for in vitro diagnostic use. 2 10/12/2006 FEI # 2623532
Abbott Diagnostic International, Ltd.
Architect FSH Calibrators (LN 6C24-01), for in vitro diagnostic use. 2 10/12/2006 FEI # 2623532
Abbott Diagnostic International, Ltd.
Abbott AxSYM system FSH Master Calibrators (LN 7A60-30), for in vitro diagnostic use. 2 10/12/2006 FEI # 2623532
Abbott Diagnostic International, Ltd.
CELL-DYN Vent Needle used on the CELL-DYN Sapphire and CELL-DYN 4000 Hematology Analyzers; CEL... 2 11/29/2010 FEI # 2919069
Abbott Diagnostics Division, 5440 Patrick Henry Drive, Santa Clara, CA
ARCHITECT HAVAB-M Reagent A chemiluminescent microparticle immunoassay (CMIA) for the qualitative... 2 05/19/2010 FEI # 2623532
Abbott Diagnostics International, Ltd.
Product Name: ID NOW" Influenza A & B 2 Model/Catalog Number: 427-000 Software Version: Not Applic... 2 03/13/2026 FEI # 1221359
Abbott Diagnostics Scarborough, Inc.
Brand Name: ID NOW COVID-19 2.0 24T Product Name: ID NOW COVID-19 2.0 24T Model/Catalog Number: 192-... 2 04/15/2025 FEI # 1221359
Abbott Diagnostics Scarborough, Inc.

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