Z-0328-2016 Class III Terminated
FDA device recall Z-0328-2016 was initiated by Biochemical Diagnostics Inc on September 14, 2015 and is designated Class III. Reason for recall: CONSULT diagnostics hCG Controls have discrepant storage temperatures listed on the kit labels when compared with the individual vial labels and the package insert. The recall status is terminated (terminated January 26, 2016). Affected quantity: Domestic: 4,473 kits.
Recall Details
- Product Type
- Devices
- Report Date
- December 2, 2015
- Initiation Date
- September 14, 2015
- Termination Date
- January 26, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- Domestic: 4,473 kits
Product Description
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.
Reason for Recall
CONSULT diagnostics hCG Controls have discrepant storage temperatures listed on the kit labels when compared with the individual vial labels and the package insert.
Distribution Pattern
US Nationwide Distribution
Code Information
Lot/Codes: KN165 (exp. 2017-09), KN169 (exp. 2017-10), KN171 (exp. 2017-11) and KN177 (exp. 2018-02)