Reported Dec 2, 2015 · Terminated
CONSULT(TM) diagnostics hCG CONTROLS Kit, Part/Reorder Number 5011, IVD Product Usage - CONSULT Diagnostics hCG…
Biochemical Diagnostics Inc.
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: Biochemical Diagnostics Inc · 180 Heartland Blvd · Edgewood, NY · 11717-8314
Is this the product you have?
- CONSULT(TM) diagnostics hCG CONTROLS Kit, Part/Reorder Number 5011, IVD Product Usage - CONSULT Diagnostics hCG Controls are intended to validate the performance of qualitative hCG urine procedures and immunochromatographic devices.
- Lot codes and dates
- Lot/CodesKN165 (exp. 2017-09), KN169 (exp. 2017-10), KN171 (exp. 2017-11) and KN177 (exp. 2018-02)
- Amount recalled
- Domestic: 4,473 kits
Where it was sold
- Nationwide
Why it was recalled
CONSULT diagnostics hCG Controls have discrepant storage temperatures listed on the kit labels when compared with the individual vial labels and the package insert.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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