Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0750-2017·Announced 2016-12-21

Roche Recalls LightMix Zika rRT-PCR Test Due to False Positive Risk

Roche Molecular Systems is recalling the LightMix Zika rRT-PCR Test because the software algorithm may occasionally report false positive results.

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. The hazard is a software algorithm error leading to false positives, which is a diagnostic accuracy issue rather than a direct physical injury or high-risk pathogen exposure. No injuries or illnesses are reported, fitting the Moderate category for minor labeling or low-risk contamination/accuracy issues.

Plain-English summary

Roche Molecular Systems, Inc. is recalling the LightMix Zika rRT-PCR Test, a real-time RT-PCR test intended for the qualitative detection of Zika virus RNA in serum or EDTA plasma. The recall involves 24 pieces of the product, catalog number 07987897001, which were distributed nationwide. The test is intended for use by trained clinical laboratory personnel under the FDA's Emergency Use Authorization.

The recall was initiated because the LightCycler 480 algorithm used for the test occasionally calls a positive result for a negative sample if there is an inflection point in the fluorescence signal. This issue occurs approximately 1% of the time. The source text does not report any specific illnesses, injuries, or deaths associated with this defect.

Consumers and laboratories should stop using the affected product. The source text does not provide specific instructions for disposal or return, but users should contact the manufacturer or relevant regulatory authorities for guidance on handling the recalled units.

The recalled product

Product: LightMix¿ Zika rRT-PCR Test The LightMix¿ Zika rRT-PCR Test is a real-time RT-PCR test intended for the qualitative detection of RNA from the Zika virus in serum or EDTA plasma from individuals meeting CDC Zika virus clinical criteria (e.g., clinical signs and symptoms…
Manufacturer: Roche Molecular Systems, Inc.
Category: Medical Device — In Vitro Diagnostics
Hazard: false-positive-result
software-defect
Affected units: 24

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)

38161611

Distribution

Distributed nationwide across the United States.

Same manufacturer · Roche Molecular Systems, Inc.

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