Alere Triage D-Dimer Test PN 98100, Lot W53884B. The Alere Triage D-Dimer Test is a fluorescence immunoassay to be used
FDA device recall Z-1727-2014 · posted 2014-06-06 · Terminated
Recall details
- Recalling firm
- Alere San Diego, Inc.
- Reason for recall
- Alere initiated this recall because a limited number of Alere Triage D-Dimer devices from PN 98100 Lot W53884B were incorrectly manufactured. As a result, when testing patient sample these affected devices will either generate an error code (e.g. E4 error), or they may generate an incorrect result.
- Action taken
- Alere sent an Urgent Medical Device Recall letter dated May 2, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers are instructed to stop using all product from the affected lot, lot W53884B, and to discard any unused product. The customers were also instructed to complete and return the verification form indicating any credit or replacement product requested. They were also instructed to contact their primary consignees and advise them of the notice. Should you have any questions about the information contained in this notification, please call (877) 308-8287. and /or email:Triage.Support@alere.com
- Root cause
- Under Investigation by firm
- Status
- Terminated
- Product code
- GHH
- Quantity affected
- 373 kits
- Distribution
- Nationwide Distribution only.
- Date initiated
- 2014-05-02
- Date posted
- 2014-06-06
- Date terminated
- 2015-02-27
- Location
- San Diego, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TRIAGE D-DIMER TEST, MODEL 98100 (K042890) | Biosite Incorporated | 2004-11-29 |