Recall Z-1928-2014 ยท NBC Test, Natriuretic Peptide
Alere San Diego, Inc.
Alere Triage BNP Calibrators for the Beckman Coulter Access Family of Immunoassay Systems, Model No. 98202 The Alere Triage BNP test is intended for use with the Beckman Coulter Access Family of Immunoassay Systems for the In Vitro quantitative measurement of B-type natriuretic peptide (BNP) in plasma specimens using EDTA as the anticoagulant. The test is intended to be used for the following ind
| Date | Jun 26, 2014 (initiated May 30, 2014) |
| Status | Terminated |
| Reason | Alere San Diego is recalling Alere Triage BNP Calibrators for the Beckman Coulter Access Family of Immunoassay Systems because the bottle labeled as Calibrator Level 5 actually contains Calibrator Level 4. This results in a calibration failure when attempting to calibrate using a calibrator kit which contains the affected Level 5 Calibrator. |
| Root cause | Error in labeling |
| Action | Alere sent an Urgent Medical Device Recall letter dated May 30, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The primary consignees were instructed to block all stock of the affected lot in their warehouses; discontinue use and return all stock on hand, complete the provided verification form to document receipt of the notice and quantity to be returned, contact their primary consignees and advise them of the required discontinuation and return of the affected lot. For customers (or their sub-distributors) |
| Quantity | 3,121 kits |
| Distribution | Worldwide Distribution - Nationwide and the countries of Australia, Canada, China, EU, Mexico, Russia, Singapore, South Africa, South Korea, Taiwan and United Arab Emirates. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.