Z-1062-2018Class II

ZYMUTEST HIA IgGAM. Model Number: RK040D. Qualitative screening assay for the detection of heparin-dependent...

Name: Z-1062-2018 ZYMUTEST HIA IgGAM. Model Number: RK040D. Qualitative screening assay for the detection of heparin-dependent...
Creator: Hyphen BioMed
Published: 2011-11-09
License: https://open.fda.gov/license/

Hyphen Biomed Sasu / initiated 2011-11-09 / Terminated

FDA source

Hyphen BioMed began a recall of ZYMUTEST HIA IgGAM. Model Number: RK040D. Qualitative screening assay for the detection of heparin-dependent antibodies (IgG, IgM and IgA isotypes by ELISA. 96... on 2011-11-09. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1062-2018
Classification: Class II
Status: Terminated
Initiated: 2011-11-09
Posted: 2018-03-15
Terminated: 2018-06-21
Recalling firm: Hyphen Biomed Sasu
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.
Product code: LCO Platelet Factor 4 Radioimmunoassay
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.
FDA root cause: Other
Action: 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.
Quantity in commerce: 94
Distribution: Worldwide Distribution - US Distribution and to the countries of : Austria and France.
Product codes and lots: UDI: 03663537018770 Lot Number: F1700415

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1062-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1062-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-21	2018-03-15
Z-1063-2018	Class II	Terminated	Voluntary: Firm initiated	2018-03-21	2018-03-15

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)