ZYMUTEST HIA MonoStrip IgGAM — Class II medical device recall Z-1063-2018
Terminated recall by Hyphen BioMed, reported 2018-03-21. A voluntary recall is initiated for ZYMUTEST HIA lgGAM - Ref RK040D - Lot F1700415 and ZYMUTEST HIA MonoStrip
| Recall number | Z-1063-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hyphen BioMed, Neuville Sur Oise, France |
| Recall initiated | 2011-11-09 |
| Classified | 2018-03-15 |
| Reported by FDA | 2018-03-21 |
| Terminated | 2018-06-21 |
| Countries outside the US | AT, FR |
| Quantity | 30 |
| UPC / GTIN / UDI-DI | 03663537046810 |
| Lot numbers | F1700416 |
| Model numbers | RK041D |
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.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1063-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.