The Recall Desk
ModerateFDA (Devices)·Z-1124-2019·Announced 2019-04-17

Roche COBAS INTEGRA 400 plus Recall for Carry-over Issues

Roche Diagnostics is recalling 656 COBAS INTEGRA 400 plus analyzers because specific tests require additional wash cycles to prevent carry-over.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any illnesses or injuries, and the hazard is related to test accuracy rather than direct physical harm, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Roche Diagnostics Corporation is recalling 656 units of the COBAS INTEGRA 400 plus analyzer. The recall is due to the need for additional extra wash cycle configurations and/or batch mode for specific tests to address carry-over issues. The affected assays include Tina-quant Apolipoprotein A-1 ver.2, Tina-quant Albumin Gen.2, Creatinine plus ver.2, and Triglycerides.

The distribution of these units was nationwide in the United States. The source text does not report any illnesses, injuries, or deaths associated with this recall. The hazard is related to the potential for carry-over in specific tests, which may affect the accuracy of the results if the required configurations are not applied.

Healthcare facilities and laboratories using these analyzers should contact Roche Diagnostics Corporation for instructions on how to implement the necessary extra wash cycle configurations or batch mode settings for the affected assays.

The recalled product

Product
COBAS INTEGRA 400 plus analyzer used in the following assays: a)Tina-quant Apolipoprotein A-1 ver.2 Catalog Number: 03032566122 b)Tina-quant Albumin Gen.2 Catalog Number 04469658190 c)Creatinine plus ver.2 Catalog Number 03263991190 d) riglycerides Catalog Number
Manufacturer
Roche Diagnostics Corporation
Category
Medical Device — Laboratory Analyzer
Hazard
Affected units
656

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)

  • All

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 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 2 products in this recall →

Related recalls

Same manufacturer · Roche Diagnostics Corporation

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Same hazard · carry over

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