Class II — Hyphen BioMed
| Recalling firm | HYPHEN BIOMED |
|---|---|
| Registered facility | HYPHEN BIOMED SASU (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Incorrect package insert indicating use of the kits with plasma, serum, and other biological fluids. The kits should only be used with plasma. |
| Product | ZYMUTEST HIA MonoStrip IgG; REF Number: RK041A; 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. |
| Quantity | 12 |
| Distribution | OH, MD, NC, NY, NH, Canada, Sweden |
| Initiated | 2018-02-05 |
| Classified | 2018-05-08 |
| Terminated | 2018-08-16 |
| Recall number | Z-1742-2018 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Hyphen BioMed (Z-1742-2018).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/79797/
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