Reported Sep 21, 2016 · Terminated
Trinity Biotech Captia Measles IgM, REF/Product Code 2326060,Test Kit for 96 Determinations, IVD
Clark Laboratories, Inc. (dba,Trinity Biotech USA)
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.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: Clark Laboratories, Inc. (dba,Trinity Biotech USA) · 2823 Girts Rd · Jamestown, NY · 14701-9666
Is this the product you have?
- Trinity Biotech Captia Measles IgM, REF/Product Code 2326060,Test Kit for 96 Determinations, IVD
- Lot codes and dates
Lot Number 2326060-043Expiration Date 31 May 2017
- Amount recalled
- US: 6 kits, Foreign: 50 kits
Where it was sold
- Nationwide
- CA
Why it was recalled
The product lot failed to meet QC acceptance criteria during stability testing. The Calibrator OD was dropping causing the positive control to be invalid (running high out of range).
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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