Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1125-2019·Announced 2019-04-17

Roche cobas c 111 and COBAS INTEGRA 400 plus analyzers recalled for carry-over

Roche Diagnostics is recalling 137 cobas c 111 and COBAS INTEGRA 400 plus analyzers because specific tests require additional wash cycles to prevent carry-over.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences, or where the probability of serious adverse health consequences is remote. No injuries or illnesses are reported in the source text.

Plain-English summary

Roche Diagnostics Corporation is recalling 137 units of cobas c 111 with ISE analyzers and COBAS INTEGRA 400 plus analyzers. The recall affects specific assays, including Creatinine plus ver.2 and Triglycerides, as well as Tina-quant Apolipoprotein A-1 ver.2 and Tina-quant Albumin Gen.2. The products were distributed nationwide in the United States.

The recall is being conducted because additional extra wash cycle configurations and/or batch mode are needed for specific tests due to carry-over. This issue may affect the accuracy of the test results.

Healthcare facilities and laboratories should contact Roche Diagnostics Corporation for instructions on how to configure the analyzers or replace the affected units. Consumers should not use the affected analyzers for the specified tests until the necessary configurations are applied.

The recalled product

Product: cobas c 111 with ISE analyzers analyzer used in the following assays: a)Creatinine plus ver.2 Catalog Number: 05401470190; b)Triglycerides Catalog Number: 04657594190 - Product Usage: Tina-quant Apolipoprotein A-1 ver.2 A lipoprotein test system is a device intended to…
Manufacturer: Roche Diagnostics Corporation
Category: Medical Device — Clinical Laboratory Analyzers
Hazard: carry-over
inaccurate-results
Affected units: 137

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)

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 →

Same manufacturer · Roche Diagnostics Corporation

See all →

Moderate
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Low
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High
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Severe
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Same hazard · carry over