Reported Dec 7, 2022 · Terminated
Trinity Biotech HbA1c (GHb) Contorls Kit, 500uL (Levels I & II), REF 01-04-0020, Part number 05-01-0040B, A1c analysis
Primus Corporation dba Trinity Biotech
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: Primus Corporation dba Trinity Biotech · 4231 E 75th Ter · Kansas City, MO · 64132-2059
Is this the product you have?
Trinity Biotech HbA1c (GHb) Contorls Kit500uL (Levels I & II)REF 01-04-0020Part number 05-01-0040BA1c analysis
- Lot codes and dates
UDI/DI 0539151674808Lot 12161
- Amount recalled
- 182 kits
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Why it was recalled
The Control Level I material value was showing results exceeding the upper limit of the acceptable range after a period of three (3) months. Additionally, per the firm, the unacceptable Control Level 1 value results in the Analyzer generating an error code which stops further testing and nullifies associated patient samples, resulting in a delay in patient results and a potential delay in therapeutic modifications.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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