Roche Anti-HAV IgM Test System Recalled for Erroneous Results
Roche Diagnostics is recalling Anti-HAV IgM test systems due to potential erroneous result messages on the cobas e 602 module.
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 3/5 (High).
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 recall is classified as FDA Class II and involves a risk of erroneous diagnostic results for a medical device, which fits the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Roche Diagnostics Corporation is recalling the Anti-HAV IgM test System, Material No. 11820591160. The recall involves 70,639 units that were distributed nationwide in the United States.
The recall is being issued because of a potential for erroneous result messages when the assay is run on the cobas e 602 module. The source text indicates that discrepant result reporting may occur, which could affect the accuracy of the laboratory diagnosis for acute or recently acquired hepatitis A virus infection.
Healthcare facilities and laboratories using the affected material should stop using the product and contact Roche Diagnostics Corporation for further instructions. The recall is classified as Class II by the FDA.
The recalled product
- Product
- Anti-HAV IgM test System, Material No. 11820591160 Product Usage: The Roche Elecsys Anti-HAV IgM immunoassay is used for the in vitro qualitative detection of IgM antibodies to hepatitis A virus (anti-HAV IgM) in human serum and plasma (potassium EDTA, lithium or sodium…
- Manufacturer
- Roche Diagnostics Corporation
- Hazard
- Affected units
- 70,639
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)
- APP-file version 04.10-101 on the cobas e 602 module.
Distribution
Distributed nationwide across the United States.
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