Recall Z-1062-2018— Hyphen BioMed
Class II · Terminated
Class II FDA medical device recall by Hyphen BioMed, initiated 2011-11-09, terminated 2018-06-21. It names one FDA 510(k) clearance: K071255. Product: ZYMUTEST HIA IgGAM. Model Number: RK040D. Qualitative screening assay for the detection of heparin-dependent antibodies (IgG, IgM and IgA isotypes by ELISA. 96 Tests.. 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..
- Recalling firm
- Hyphen BioMed
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2011-11-09
- Terminated
- 2018-06-21
- Firm location
- Neuville Sur Oise, France
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
ZYMUTEST HIA IgGAM. Model Number: RK040D. Qualitative screening assay for the detection of heparin-dependent antibodies (IgG, IgM and IgA isotypes by ELISA. 96 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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.