Recall Z-2881-2011 ยท DKZ Enzyme Immunoassay, Amphetamine
Alere San Diego
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.
| Date | Jul 27, 2011 (initiated Jun 10, 2011) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Vendor change control |
| 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 InnovaconComplaints@alere.com. |
| Quantity | 2400 kits (60,000 devices) |
| Distribution | (USA) Nationwide Distribution including the states of MO and MA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K061718 | INNOVACON SPECTRUM II TEST CARD Innovacon, Inc., Nov 13, 2006 |