ZYMUTEST HIA IgGAM RK040DRecalls & reported problems

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier.

7 other recalls cover devices cleared under the same FDA submission (K071255); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Nov 9, 2011Class IITerminated

   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.

   Z-1062-2018 · Root cause: Other · Recall details · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K071255. One submission often covers many models, so check the product and lot details in each record.

• Z-2171-2026 · Apr 1, 2026 · Open, Classified
  ZYMUTEST HIA IgG, in vitro diagnostic ELISA kit, Ref. RK040A
• Z-2347-2019 · Jul 19, 2019 · Terminated
  ZYMUTEST HIA MonoStrip, IgGAM ELISA kit, Model No. RK041D, for in vitro diagnostic use.
• Z-2346-2019 · Jul 19, 2019 · Terminated
  ZYMUTEST HIA MonoStrip, IgG ELISA kit, Model No. RK041A, for in vitro diagnostic use.
• Z-1742-2018 · Feb 5, 2018 · Terminated
  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 plas
• Z-1744-2018 · Feb 5, 2018 · Terminated
  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
• Z-1743-2018 · Feb 5, 2018 · 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
• Z-1063-2018 · Nov 9, 2011 · Terminated
  ZYMUTEST HIA MonoStrip IgGAM. Model Number: RK041D. Qualitative screening assay for the detection of heparin-dependent antibodies (IgG, IgM and IgA isotypes by ELISA. 32 Tests.