Reported Feb 9, 2022 · Terminated
ARIES HSV 1&2 Assay, Catalog/REF# 50-10017
Luminex Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Luminex Corporation · 12212 Technology Blvd · Austin, TX · 78727-6101
Is this the product you have?
ARIES HSV 1&2 AssayCatalog/REF# 50-10017
- Lot codes and dates
- Lot Numbers AB3600A and AB3560A
- Amount recalled
- 329
Where it was sold
Why it was recalled
Impacted lot may leak inside the ARIES instrument. Testing confirmed a leak rate of 0.9%. Leaking cassettes could potentially lead to incorrect results or a delay in reporting results due to an Invalid.
This product could cause temporary or reversible health problems — stop using it.
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