Alere Triage TOX Drug Screen Control 1 Product Generic Name: Quality Control Material Description of the product: Good L
FDA device recall Z-0053-2014 · posted 2013-10-23 · Terminated
Recall details
- Recalling firm
- Alere San Diego, Inc.
- Reason for recall
- 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.
- Action taken
- 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 using Alere Triage TOX Drug Screen products. Customers were instructed to discontinue use of and discard the CODE CHIP contained within the Alere Triage TOX Drug Screen Control 1 PN 94413 Lot C2681A kit box. Customers were also instructed to provide a copy of the notice to their customers and instruct them to contact Alere for a replacement code chip. Customers were asked to complete and fax the enclosed Verification Form to confirm their receipt of the notice. Customers with questions were instructed to contact: (Alere San Diego, Inc. 9975 Summers Ridge Road San Diego, CA 92121, U.S.A. Phone: 877 308 8287 FAX: 858 805 8457 E-mail: Responses.ts@alere.com). For questions regarding this recall call 858-805-2000, ext 3015.
- Root cause
- Under Investigation by firm
- Status
- Terminated
- Product code
- DIF
- Quantity affected
- 38
- Distribution
- Worldwide Distribution - USA (nationwide) and countries of: South Africa and Canada.
- Date initiated
- 2013-09-23
- Date posted
- 2013-10-23
- Date terminated
- 2014-09-26
- Location
- San Diego, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TRIAGE TOX DRUG SCREEN CONTROL LEVEL 1 MODEL 94413 AND LEVEL 2 MODEL 94414 (K060788) | Biosite Incorporated | 2006-07-10 |