Reported May 16, 2018 · Terminated
ZYMUTEST HIA MonoStria qualitative screening assay intended for the global detection of heparin-dependent antibodies,…
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?
ZYMUTEST HIA MonoStria qualitative screening assay intended for the global detection of heparin-dependent antibodies, whether the isotype is
3 of 3 products
| # | Barcodes | Product as published |
|---|---|---|
| 1 | IgG, IgM and IgA, in human plasma, by clinical laboratories. p IgGAM | |
| 2 | REF Number: RK041D | |
| 3 | 03663537046810 | UDI: 03663537046810 |
- Lot codes and dates
- Lot numbers
F1600568P1F1701370P1F1701370P2
- Lot numbers
- Amount recalled
- 60
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.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Hyphen BioMed recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.