Reported Mar 21, 2018 · Terminated
ZYMUTEST HIA MonoStrip IgGAM. Model Number: RK041D. Qualitative screening assay for the detection of heparin-dependent…
Hyphen BioMed
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: Hyphen BioMed · 155 rue d Eragny · Neuville Sur Oise · N/A
Is this the product you have?
- ZYMUTEST HIA MonoStrip IgGAM
- Model NumberRK041D. Qualitative screening assay for the detection of heparin-dependent antibodies (IgG, IgM and IgA isotypes by ELISA. 32 Tests
- Lot codes and dates
- UDI03663537046810
- Lot NumberF1700416
- Amount recalled
- 30
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
A voluntary recall is initiated for ZYMUTEST HIA lgGAM - Ref RK040D - Lot F1700415 and ZYMUTEST HIA MonoStrip lgGAM - Ref RK041D - Lot F1700416 because they may produce false positive results.
This product could cause temporary or reversible health problems — stop using it.
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