ZYMUTEST HIA MonoStrip IgGAM. Model Number: RK041D. Qualitative screening assay for the detection of heparin-dependent a
FDA device recall Z-1063-2018 · posted 2018-03-15 · Terminated
Recall details
- Recalling firm
- Hyphen BioMed
- 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.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- LCO
- Quantity affected
- 30
- Distribution
- Worldwide Distribution - US Distribution and to the countries of : Austria and France.
- Date initiated
- 2011-11-09
- Date posted
- 2018-03-15
- Date terminated
- 2018-06-21
- Location
- Eragny Neuville Sur Oise, France
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ZYMUTEST HIA IGGAM, ZYMUTEST IGG, MODEL RK040D, RK040A (K071255) | Hyphen Biomed | 2007-09-07 |