FDA (Devices) recall action 79269
The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.
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.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Hyphen BioMed is voluntarily recalling ZYMUTEST HIA IgGAM and MonoStrip assays because they may produce false positive results.
Hyphen BioMed is voluntarily recalling ZYMUTEST HIA assays because they may produce false positive results. The recall affects specific lots distributed in the US, Austria, and France.