Device product
CONSULT(TM) diagnostics hCG CONTROLS Kit, Part/Reorder Number 5011, IVD Product Usage - CONSULT Diagnostics hCG Controls are intended to validate the performance of qualitative hCG urine procedures and immunochromatographic devices.
Z-0328-2016
Product summary
- Event
- Event 72197
- Status
- Terminated
- Classification
- Class III
- Quantity
- Domestic: 4,473 kits
- Official record key
device-enforcement:Z-0328-2016
Official wording
Reason: CONSULT diagnostics hCG Controls have discrepant storage temperatures listed on the kit labels when compared with the individual vial labels and the package insert.
Code information: Lot/Codes: KN165 (exp. 2017-09), KN169 (exp. 2017-10), KN171 (exp. 2017-11) and KN177 (exp. 2018-02)
Distribution pattern: US Nationwide Distribution
Derived failure modes
-
Unknown
CONSULT diagnostics hCG Controls have discrepant storage temperatures listed on the kit labels when compared with the individual vial labels and the package insert.