FDA Enforcement
Class III
Terminated
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.
Recall: Z-0328-2016
·
Reported December 2, 2015
Enforcement
- Recall Number
- Z-0328-2016
- Event ID
- 72197
- Classification
- Class III
- Status
- Terminated
- Product Type
- Devices
- Firm
- Biochemical Diagnostics Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- December 2, 2015
- Initiation Date
- September 14, 2015
- Classification Date
- November 23, 2015
- Termination Date
- January 26, 2016
- Address
- 180 Heartland Blvd, N/A, Edgewood, NY, 11717-8314, United States
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
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 Info
Lot/Codes: KN165 (exp. 2017-09), KN169 (exp. 2017-10), KN171 (exp. 2017-11) and KN177 (exp. 2018-02)
Distribution
US Nationwide Distribution
Quantity
Domestic: 4,473 kits