Reported May 16, 2018 · Terminated
ZYMUTEST HIA IgGAM; REF Number: RK040D; UDI: 03663537018770 a qualitative screening assay intended for the global…
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 IgGAM | |
| 2 | REF Number: RK040D | |
| 3 | 03663537018770 | UDI: 03663537018770 a qualitative screening assay intended for the global detection of heparin- dependent antibodies, whether the isotype is: IgG, IgM and IgA, in human plasma, by clinical laboratories. |
- Lot codes and dates
- Lot numbers
F1600568P1F1600568P2F1700415P1F1700415P2F1701369P1F1701369P2
- Lot numbers
- Amount recalled
- 281
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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