Roche Lactate Gen.2 Recalled Due to Endogenous Interference Claims
Roche Diagnostics is recalling Lactate Gen.2 reagents because new endogenous interference claims may affect test accuracy on specific analyzers.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The source text explicitly states that the interference claims 'may have potential medical risk,' which aligns with the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Roche Diagnostics Corporation is recalling Lactate Gen.2, an in vitro diagnostic reagent system intended for use on the cobas Integra for the quantitative determination of lactate concentration in plasma and cerebrospinal fluid. The recall involves 5,292 analytical units distributed nationwide in the United States.
The recall was initiated because new endogenous interference claims have been established for assays used on the cobas c 311 analyzer and the cobas c 501, 502, 701, 702, and Modular Analytics P/D modules. An update to the recall notice indicates that the Cobas c111 and COBAS INTEGRA 400 plus analyzers are also impacted for BILT3 and LACT2 assays. These interference issues may pose a potential medical risk.
Healthcare facilities and laboratories that have received or are using these specific catalog numbers (03183700190, 05171881190, 11822837190) should stop using the product and contact Roche Diagnostics for instructions on return or replacement.
The recalled product
- 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 ce
- Manufacturer
- Roche Diagnostics Corporation
- Affected units
- 5,292
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- n/a
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Roche Diagnostics Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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