Recall Z-0328-2016
Biochemical Diagnostics Inc · initiated September 14, 2015
Class III – products unlikely to cause any adverse health reaction but that violate FDA labeling or manufacturing laws
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.
Codes / lots: Lot/Codes: KN165 (exp. 2017-09), KN169 (exp. 2017-10), KN171 (exp. 2017-11) and KN177 (exp. 2018-02)
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.
FDA-determined cause: Labeling False and Misleading
Action taken
Biochemical Diagnostics sent a Notice of Correction Letter (dated August 26, 2015) to customers via USPS 1st class mail. The letter identified the affected product, problem and actions to be taken. Customers were instructed to return the verification form, per the notification. For questions contact Alere Technical Service at 866-216-0094 or by email at verifications.at verifications.ts@alere.com.
Details
- Recall number
- Z-0328-2016
- Initiated
- September 14, 2015
- Posted by FDA
- November 23, 2015
- Terminated
- January 26, 2016
- Product code
- JJX – Single (Specified) Analyte Controls (Assayed And Unassayed)
- Quantity
- Domestic: 4,473 kits
- Distribution
- US Nationwide Distribution
- Recalling firm
- Biochemical Diagnostics Inc, Edgewood, NY