Reported May 16, 2018 · Terminated
ZYMUTEST HIA MonoStrip IgG; REF Number: RK041A; UDI: 03663537046803 a qualitative assay intended for the detection of…
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 · N/A
Is this the product you have?
3 of 3 products
| # | Barcodes | Product as published |
|---|---|---|
| 1 | ZYMUTEST HIA MonoStrip IgG | |
| 2 | REF Number: RK041A | |
| 3 | 03663537046803 | UDI: 03663537046803 a qualitative assay intended for the detection of heparin-dependent antibodies of the IgG isotype, in human plasma, by clinical laboratories. It is intended for in vitro diagnostic use. |
- Lot codes and dates
- Lot numbersF1701084P2 and F1701084P3
- Amount recalled
- 12
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
Incorrect package insert indicating use of the kits with plasma, serum, and other biological fluids. The kits should only be used with plasma.
This product could cause temporary or reversible health problems — stop using it.
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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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