Reported Apr 24, 2019 · Terminated
Lactate Gen.2, Catalog Nos. 03183700190, 05171881190, 11822837190, ***added as of 5/10/19*** 03183700190 Product Usage:…
Roche Diagnostics Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Roche Diagnostics Corporation · 9115 Hague Rd · Indianapolis, IN · 46256-1025
Is this the product you have?
Lactate Gen.2Catalog Nos. 031837001900517188119011822837190***added as of 5/10/19*** 03183700190
- Product UsageAn In vitro diagnostic reagent system intended for use on cobas Integra for the quantitative determination of the lactate concentration in plasma and cerebrospinal fluid
- Lot codes and dates
- n/a
- Amount recalled
- 5292 analytical units
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
- Nationwide
Why it was recalled
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***
This product could cause temporary or reversible health problems — stop using it.
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