Recall Z-2881-2011
Alere San Diego · initiated June 10, 2011
Product
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.
Codes / lots: Model/Catalog Number: DOA-197-201-19-0NW506A, Lot/Unit Codes: DOA1040725, DOA1040758, DOA1040784, DOA1040669 & DOA1040689
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.
FDA-determined cause: Vendor change control
Action taken
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 InnovaconComplaints@alere.com.
Details
- Recall number
- Z-2881-2011
- Initiated
- June 10, 2011
- Posted by FDA
- July 27, 2011
- Terminated
- April 4, 2012
- Product code
- DKZ – Enzyme Immunoassay, Amphetamine
- Quantity
- 2400 kits (60,000 devices)
- Distribution
- (USA) Nationwide Distribution including the states of MO and MA.
- Recalling firm
- Alere San Diego, San Diego, CA