Recall Z-1063-2018 ยท LCO Platelet Factor 4 Radioimmunoassay
Hyphen BioMed
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.
| Date | Mar 15, 2018 (initiated Nov 9, 2011) |
| 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. |
| Root cause | Other |
| Action | The manufacturer, HYPHEN BioMed, initiated a voluntary recall of the two lots via email. Distributors and end users are being notified and instructed to: 1) acknowledge receipt and understanding of notification, and 2) destroy affected products remaining in stock. For further questions, please call (513) 770-1993. |
| Quantity | 30 |
| Distribution | Worldwide Distribution - US Distribution and to the countries of : Austria and France. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K071255 | ZYMUTEST HIA IGGAM, ZYMUTEST IGG, MODEL RK040D, RK040A Hyphen Biomed, Sep 7, 2007 |