Z-1744-2018Class II

ZYMUTEST HIA IgGAM; REF Number: RK040D; UDI: 03663537018770 a qualitative screening assay intended for the...

Name: Z-1744-2018 ZYMUTEST HIA IgGAM; REF Number: RK040D; UDI: 03663537018770 a qualitative screening assay intended for the...
Creator: Hyphen BioMed
Published: 2018-02-05
License: https://open.fda.gov/license/

Hyphen Biomed Sasu / initiated 2018-02-05 / Terminated / root cause: packaging

FDA source

Hyphen BioMed began a recall of ZYMUTEST HIA IgGAM; REF Number: RK040D; UDI: 03663537018770 a qualitative screening assay intended for the global detection of heparin- dependent antibodies... on 2018-02-05. FDA classified it as Class II and gives the reason as "Incorrect package insert indicating use of the kits with plasma, serum, and other biological fluids. The kits should only be used with plasma". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1744-2018
Classification: Class II
Status: Terminated
Initiated: 2018-02-05
Posted: 2018-05-08
Terminated: 2018-08-16
Recalling firm: Hyphen Biomed Sasu
Product: ZYMUTEST HIA IgGAM; REF Number: RK040D; UDI: 03663537018770 a 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.
Product code: LCO Platelet Factor 4 Radioimmunoassay
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.
Root cause tag: packaging
FDA root cause: Packaging process control
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.
Quantity in commerce: 281
Distribution: OH, MD, NC, NY, NH, Canada, Sweden
Product codes and lots: Lot numbers: F1600568P1, F1600568P2, F1700415P1, F1700415P2, F1701369P1, F1701369P2

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1744-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1742-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-16	2018-05-08
Z-1743-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-16	2018-05-08
Z-1744-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-16	2018-05-08

Product code LCO

K071255Class IIZymutest Hia Iggam, Zymutest Igg, Model Rk040d, Rk040aHyphen Biomed / cleared 2007-09-07

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)