Recall Z-0053-2014 ยท DIF Drug Mixture Control Materials
Alere San Diego, Inc.
Alere Triage TOX Drug Screen Control 1 Product Generic Name: Quality Control Material Description of the product: Good Laboratory Practice suggests that external controls should be tested with each new lot or shipment of test materials, or every 30 days, and as otherwise required by a laboratorys standard quality control procedures. The Alere Triage Drug Screen Controls, when used in accordance
| Date | Oct 23, 2013 (initiated Sep 23, 2013) |
| Status | Terminated |
| Reason | Alere San Diego, Inc. initiated a voluntary recall of Alere Triage TOX Drug Screen Control 1 (PN 94413, Lot C2681A) because the CODE CHIP that was provided with this lot causes the control to fail when run in the QC Sample Mode using Alere Triage TOX Drug Screeen products. The Alere Triage TOX Drug Screen test devices and patient results are not affected. |
| Root cause | Under Investigation by firm |
| Action | Alere San Diego, Inc. sent an Urgent Medical Device Notice dated September 23, 2013, to all affected customers via FedEx and outside US (OUS) consignees on September 24, 2013, via email. The customer notification letter titled "URGENT MEDICAL DEVICE NOTICE", informed customers of the recall, product description with part number and lot code (Alere Triage TOX Drug Screen Control 1 PN 94413 Lot C2681A), reason for recall and impact (The purpose of the letter was to inform customers that the CODE CHIP" that was provided with this lot causes the control to fail when run in the QC Sample Mode usin |
| Quantity | 38 |
| Distribution | Worldwide Distribution - USA (nationwide) and countries of: South Africa and Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K060788 | TRIAGE TOX DRUG SCREEN CONTROL LEVEL 1 MODEL 94413 AND LEVEL 2 MODEL 94414 Biosite Incorporated, Jul 10, 2006 |