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Terminated

ZYMUTEST HIA MonoStria qualitative screening assay intended for the global detection of heparin-dependent antibodies, whether the isotype is: IgG, IgM and IgA, in human plasma, by clinical laboratories. p IgGAM; REF Number: RK041D; UDI: 03663537046810

FDA Recall Z-1743-2018 · Posted None

Recalling FirmHyphen BioMed
Recall StatusTerminated
Product CodeLCO
Date Initiated2018-02-05
Date Terminated2018-08-16
Product Quantity60

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.

K071255ZYMUTEST HIA IGGAM, ZYMUTEST IGG, MODEL RK040D, RK040AHyphen Biomed · 2007-09-07

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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