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U.S. Department of Health and Human Services

Medical Device Recalls
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1 to 8 of 8 Results
510(K) Number: K042272
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Stanbio Rely Mono Rapid Test, Catalog No. 6200-010L and 6200-020L a simple test that utilizes an e... 3 07/22/2016 FEI # 1000125596
Alere San Diego, Inc.
Signify Mono (Whole Blood, Serum, Plasma), Catalog No. 01P52-25 a simple test that utilizes an ext... 3 07/22/2016 FEI # 1000125596
Alere San Diego, Inc.
Proadvantage Mono Rapid Test Cassette, Catalog No. P080016 a simple test that utilizes an extract ... 3 07/22/2016 FEI # 1000125596
Alere San Diego, Inc.
IMO-402 Mononucleosis Rapid Test Device (Whole Blood/Serum/Plasma). Catalog #IMO-402/94201 The M... 3 04/18/2013 FEI # 1000125596
Alere San Diego, Inc.
Henry Schein One Step + Mono Rapid Test Device, Catalog No. 9004070 a simple test that utilizes an e... 3 07/22/2016 FEI # 1000125596
Alere San Diego, Inc.
Clearview MONO (Whole Blood, Serum, Plasma), Catalog No. 92401 a simple test that utilizes an extr... 3 07/22/2016 FEI # 1000125596
Alere San Diego, Inc.
Cardinal Health Mono Rapid Test, Catalog No. B1077-28, a simple test that utilizes an extract of b... 3 07/22/2016 FEI # 1000125596
Alere San Diego, Inc.
Acceava Mono II Rapid Test Strip (Whole Blood, Serum, Plasma), Catalog No. 92404. Mononucleosis Rap... 3 07/22/2016 FEI # 1000125596
Alere San Diego, Inc.
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