Recall Z-0328-2016 ยท JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
Biochemical Diagnostics Inc
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.
| Date | Nov 23, 2015 (initiated Sep 14, 2015) |
| Status | Terminated |
| 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. |
| Root cause | Labeling False and Misleading |
| Action | 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. |
| Quantity | Domestic: 4,473 kits |
| Distribution | US Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K050328 | PREGNANCY-SKREEN Biochemical Diagnostic, Inc., Mar 29, 2005 |