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U.S. Department of Health and Human Services

Medical Device Recalls
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510(K) Number: K141520
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Alere i flu, Alere i, Alere Influenza A & B; Part Number (PN) 425-024 The Alere" i Influenza A & B ... 2 07/16/2015 FEI # 1221359
Alere Scarborough, Inc. dba Binax, Inc.
Alere i Influenza A & B Product Usage: The Alere i Influenza A and B assay, performed on the Ale... 2 05/26/2015 FEI # 1221359
Alere Scarborough, Inc. dba Binax, Inc.
Influenza Transport Swab Packages, Reference #20171, One lot with 1010 packages (each package conta... 2 02/22/2017 FEI # 2024674
Quidel Corporation
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