FDA DeviceClass IINotable
FDA Recall: ZYMUTEST HIA IgG, in vitro diagnostic ELISA kit, Ref. RK040A
Description
Kits from lot FD1265 had been packaged on 17 October 2024 and put on the market with an outdated flyer (8 October 2024), containing incorrect values for the positive control.
Hazard
Kits from lot FD1265 had been packaged on 17 October 2024 and put on the market with an outdated flyer (8 October 2024), containing incorrect values for the positive control.
Remedy
359 units
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