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 | 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. |
| Product | ZYMUTEST HIA MonoStrip IgGAM. Model Number: RK041D. Qualitative screening assay for the detection of heparin-dependent antibodies (IgG, IgM and IgA isotypes by ELISA. 32 Tests. |
| Quantity | 30 |
| Distribution | Worldwide Distribution - US Distribution and to the countries of : Austria and France. |
| Initiated | 2011-11-09 |
| Classified | 2018-03-15 |
| Terminated | 2018-06-21 |
| Recall number | Z-1063-2018 |
| 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-1063-2018).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/79269/
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