Recall Z-1214-2014 ยท DJR Enzyme Immunoassay, Methadone
Alere San Diego, Inc.
Product Brand Name(s): Alere Triage TOX+MTD Drug Screen, Catalog Number 94400, Lots W56013B and W56035B. 25 individually pouched devices in a labeled kit box. Indications for use: The Alere Triage TOX Drug Screen is a fluorescence immunoassay to be used with the Alere Triage Meters for the qualitative determination of the presence of drug and/or the major metabolites above the threshold concentr
| Date | Mar 17, 2014 (initiated Feb 5, 2014) |
| Status | Terminated |
| Reason | Alere San Diego, Inc. is initiating a recall of the Alere Triage TOX Drug Screen, Catalog Number 94400, Lots W56013B and W56035B because Alere's investigation has shown that these lots have a frequency of false negative results for PCP (Phencyclidine) that is higher than the frequency shown in the package insert. If you have questions about previously reported results. |
| Root cause | Process control |
| Action | Alere San Diego, Inc. sent out recall notification letters to customers via direct mail or email. The letter, dated February 3, 2014, titled "URGENT MEDICAL DEVICE RECALL", provided customers the following information: product description with codes, reason for recall, impact, contact information and customer/distributor required actions. A Customer/Distributor Verification Form was provided. Customers were instructed to discontinue use and discard the affected lots. Alternately, if you elect to continue to use the product customers must verify if it will not be used to report results for P |
| Quantity | 305 kits (239 kits of W56013B, 66 kits of W56035B) |
| Distribution | Worldwide Distribution - USA (nationwide) and Internationally to Taiwan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K060791 | TRIAGE TOX DRUG SCREEN, MODEL 94400 Biosite Incorporated, Jun 22, 2006 |