Recall Z-1727-2014 ยท GHH Fibrin Split Products
Alere San Diego, Inc.
Alere Triage D-Dimer Test PN 98100, Lot W53884B. The Alere Triage D-Dimer Test is a fluorescence immunoassay to be used with the Alere Triage Meters for the quantitative determination of cross-linked fibrin degradation products containing D-dimer in EDTA anticoagulated whole blood and plasma specimens. . The Alere Triage D-Dimer test is intended for use as an aid in the assessment and evaluation o
| Date | Jun 6, 2014 (initiated May 2, 2014) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Under Investigation by firm |
| Action | 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 c |
| Quantity | 373 kits |
| Distribution | Nationwide Distribution only. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K042890 | TRIAGE D-DIMER TEST, MODEL 98100 Biosite Incorporated, Nov 29, 2004 |