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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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Z-1145-2019 - Bilirubin Total Gen.3, Cat. Nos. 05795397190, 05795419190, 05795320160, 05795338160, 05795346160 ***added as of 5/10/19***05795397190, 05795648190 Product Usage: In vitro test for the quantitat... 2 04/13/2019 Roche Diagnostics Corporation
Z-1147-2019 - Tina-quant IgM Gen.2, Catalog Nos. 03507190190, 05220726190, 03507041190, 03507149190 Product Usage: Immunoturbidimetric assay for the quantitative in vitro determination of IgM in human serum and... 2 04/13/2019 Roche Diagnostics Corporation
Z-1146-2019 - Lactate Gen.2, Catalog Nos. 03183700190, 05171881190, 11822837190, ***added as of 5/10/19*** 03183700190 Product Usage: An In vitro diagnostic reagent system intended for use on cobas Integra ... 2 04/13/2019 Roche Diagnostics Corporation
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