The Recall Desk
SevereFDA (Devices)·Z-1147-2019·Announced 2019-04-24

Roche Tina-quant IgM Gen.2 Recalled for Endogenous Interference

Roche Diagnostics is recalling Tina-quant IgM Gen.2 assays due to new endogenous interference claims that may pose a medical risk on specific analyzers.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classification is Class II, and the source text explicitly states the issue 'may have potential medical risk,' which aligns with the rubric criteria for Severe severity involving significant injury or risk-of-harm products.

Plain-English summary

Roche Diagnostics Corporation is recalling 5,292 analytical units of Tina-quant IgM Gen.2 assays. The affected catalog numbers are 03507190190, 05220726190, 03507041190, and 03507149190. These products are immunoturbidimetric assays used for the quantitative in vitro determination of IgM in human serum and plasma on automated clinical chemistry analyzers.

The recall was initiated because new endogenous interference claims have been established for the assays. This issue may have potential medical risk when the assays are used on the cobas c 311 analyzer, the cobas c 501, 502, 701, and 702, and Modular Analytics P/D modules. An update to the recall indicates that Cobas c111 and COBAS INTEGRA 400 plus analyzers are also impacted for BILT3 and LACT2 assays.

The product was distributed nationwide in the United States. Healthcare facilities and laboratories should stop using the affected assays and contact Roche Diagnostics Corporation for further instructions on the recall.

The recalled product

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.
Manufacturer
Roche Diagnostics Corporation
Category
Medical Device — In Vitro Diagnostics
Hazard
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.

See all 3 products in this recall →

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