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U.S. Department of Health and Human Services

Medical Device Recalls

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Related Medical Device Recalls
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Product Description
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FDA Recall
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Z-0396-2017 - COBAS INTEGRA 800 Tina-Quant Hemoglobin A1cDX Gen.2 Hemoglobin A1cDX test Catalog number 04528123160 2 11/11/2016 Roche Diagnostics Operations, Inc.
Z-0395-2017 - Tina-Quant Hemoglobin A1c Gen. 2 Hemoglobin A1c test Catalog number 04528123190 / 05401640190 2 11/11/2016 Roche Diagnostics Operations, Inc.
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