Device product
ZYMUTEST HIA IgG, in vitro diagnostic ELISA kit, Ref. RK040A
Z-2171-2026
Product summary
- Event
- Event 98754
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 359 units
- Official record key
device-enforcement:Z-2171-2026
Official wording
Reason: Kits from lot FD1265 had been packaged on 17 October 2024 and put on the market with an outdated flyer (8 October 2024), containing incorrect values for the positive control.
Code information: UDI-DI: 03663537018763; Lot Number: FD1265
Distribution pattern: US Nationwide distribution in the states of CA, GA, MN, MO, NC, NM, NY, VA, WA, and WI
Derived failure modes
-
Unknown
Kits from lot FD1265 had been packaged on 17 October 2024 and put on the market with an outdated flyer (8 October 2024), containing incorrect values for the positive control.