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.
FDA Recall Z-1742-2018 · Posted None
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Recalling FirmHyphen BioMed
Recall StatusTerminated
Product CodeLCO
Date Initiated2018-02-05
Date Terminated2018-08-16
Product Quantity12
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.
Firm Action
On March 6, 3018 Aniara Diagnostica began emailing Urgent Medical Device Recall notifications to affected customers. Customers are instructed to: Use the US Instructions for Use and Return the completed Acknowledgement Awareness Form. Customers with questions may contact Aniara Diagnostica via e-mail at [email protected] or by phone at (866)783-3797 ext. 110.
Root Cause
Packaging process control
Distribution Pattern
OH, MD, NC, NY, NH, Canada, Sweden
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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