ZYMUTEST HIA IgGAM — Class II medical device recall Z-1744-2018
Terminated recall by Hyphen BioMed, reported 2018-05-16, distributed in MD, NC, NH, NY, OH. Incorrect package insert indicating use of the kits with plasma, serum, and other biological fluids. The kits
| Recall number | Z-1744-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hyphen BioMed, Neuville Sur Oise, N/A, France |
| Recall initiated | 2018-02-05 |
| Classified | 2018-05-08 |
| Reported by FDA | 2018-05-16 |
| Terminated | 2018-08-16 |
| Distributed | MD, NC, NH, NY, OH |
| Countries outside the US | CA, SE |
| Quantity | 281 |
| UPC / GTIN / UDI-DI | 03663537018770 |
| Lot numbers | F1600568P1, F1600568P2, F1700415P1, F1700415P2, F1701369P1, F1701369P2 |
| Model numbers | RK040D |
Product
ZYMUTEST HIA IgGAM; REF Number: RK040D; 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.
Reason for recall
Incorrect package insert indicating use of the kits with plasma, serum, and other biological fluids. The kits should only be used with plasma.
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-1744-2018. 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.