Product Brand Name(s): Alere Triage TOX+MTD Drug Screen, Catalog Number 94400, Lots W56013B and W56035B. 25 individually
FDA device recall Z-1214-2014 · posted 2014-03-17 · Terminated
Recall details
- Recalling firm
- Alere San Diego, Inc.
- Reason for recall
- 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.
- Action taken
- 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 PCP. Customers were instructed to return the Customer Verification Form by fax to 858-805-8457 with the amount of product they have for credit. The information should be shared with their laboratory staff and the notification should be retained as part of their laboratory Quality System documentation. If the product has been forwarded customers were instructed to provide a copy of the letter to them. Customers with questions were instructed to contact Alere San Diego, Inc. at 877-308-8287 or email Triage.Support@alere.com. For questions regarding this recall call 858-805-2000, ext 3015.
- Root cause
- Process control
- Status
- Terminated
- Product code
- DJR
- Quantity affected
- 305 kits (239 kits of W56013B, 66 kits of W56035B)
- Distribution
- Worldwide Distribution - USA (nationwide) and Internationally to Taiwan.
- Date initiated
- 2014-02-05
- Date posted
- 2014-03-17
- Date terminated
- 2014-10-27
- Location
- San Diego, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TRIAGE TOX DRUG SCREEN, MODEL 94400 (K060791) | Biosite Incorporated | 2006-06-22 |