Calloway LabsMulti-Drug 9 Panel Assay A rapid, one step screening test for the simultaneous for the qualitative detection of multiple drugs and drug metabolites in human urine.
FDA Recall Z-2881-2011 · Posted 2011-07-27
Recalling FirmAlere San Diego
Recall StatusTerminated
Product CodeDKZ
Date Initiated2011-06-10
Date Terminated2012-04-04
Product Quantity2400 kits (60,000 devices)
Reason for Recall
Alere is initiating a voluntary recall on the listed lots of MULTI-DRUG 9 PANEL INTEGRATED CUP manufactured by Alere for sole use by Calloway Labs due to a mistake that occurred while processing the order, these products were incorrectly
labeled as CLIA Waived, when in fact the devices are classified as Moderately Complex. Therefore these devices are misbranded.
Firm Action
Alere San Diego sent an "Urgent Medical Device Recall" letter dated June 9, 2011 to all affected customers.
The letter included: products affected, reason for recall and instructed them to return all affected product. An acknowledgement form was also included for the customer to return to Alere.
For questions contact Technical Services at 888.246.7483, option 2 or by e-mail at [email protected].
Root Cause
Vendor change control
Distribution Pattern
(USA) Nationwide Distribution including the states of MO and MA.
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.