FDA Device recall Z-1742-2018
ZYMUTEST HIA MonoStrip IgG
- FDA Device
- Class II
- terminated
- Published 2018-05-16
On 2018-05-16 the FDA classified a Class II recall of ZYMUTEST HIA MonoStrip IgG by Hyphen Biomed, citing incorrect package insert indicating use of the kits with plasma, serum, and other biological fluids. The kits should only be used with plasma.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1742-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-02-05 |
| Published | 2018-05-16 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Hyphen Biomed |
| Distribution | MD, NC, NH, NY, OH |
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.
Reason
Incorrect package insert indicating use of the kits with plasma, serum, and other biological fluids. The kits should only be used with plasma.
Identifiers
| code_info | Lot numbers: F1701084P2 and F1701084P3 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1742-2018%22
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