Roche Diagnostics Corporation: New endogenous interference claims have been established for the following assays used on the cobas c 311 analyzer and the cobas c 501, 502, 701, 702, and Modular Analytics P/D modules which may have potential medical risk. Update: Cobas c111 and COBAS INTEGRA 400 plus analyzers are also impacted for BILT3 and LACT2 assays

Agency Publication Date: April 13, 2019

Affected Products

Product: 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 quantitative determination of total bilirubin in serum and plasma of adults and neonates on Roche/Hitachi cobas c systems.

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Product: 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 for the quantitative determination of the lactate concentration in plasma and cerebrospinal fluid.

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Product: 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 plasma on automated clinical chemistry analyzers analyzers.

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Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 81859

Status: Resolved

Manufacturer: Roche Diagnostics Corporation

Manufactured In: United States

Units Affected: 3 products (5292 analytical units)

Agency Last Updated: May 14, 2019

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

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Affected Products

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