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.
FDA Recall Z-0328-2016 · Posted 2015-11-23
Advertisement
Recalling FirmBiochemical Diagnostics Inc
Recall StatusTerminated
Product CodeJJX
Date Initiated2015-09-14
Date Terminated2016-01-26
Product QuantityDomestic: 4,473 kits
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.
Firm 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 [email protected].
Root Cause
Labeling False and Misleading
Distribution Pattern
US Nationwide Distribution
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement