Recall Z-1540-2014 ยท NBC Test, Natriuretic Peptide
Alere San Diego, Inc.
Alere Triage BNP Test for the Beckman Coulter Access Family of Immunoassay Systems, Model Number 98200, Lot Numbers: 329599, 331265. The Alere Triage BNP test is intended to be used as an aid in the diagnosis of congestive heart failure (heart failure), as an aid in the assessment of severity of congestive heart failure, for the risk stratification of patients with acute coronary syndromes
| Date | May 2, 2014 (initiated Mar 20, 2014) |
| Status | Terminated |
| Reason | These lots may not recover within range when tested using certain commercially available controls. |
| Root cause | Under Investigation by firm |
| Action | Alere San Diego, Inc. initiated this recall by sending out notification letters via email and/or regular mail on March 20, 2014. The letter titled "URGENT MEDICAL DEVICE CORRECTION", dated "March 20, 2014, informed customers of the reason for recall, and potential impact, product description with lots numbers, customer/distributor required action, and contact information. The letter was accompanied by a "Customer/Distributor Verification Form". Customers were instructed that they may continue to use reagent lots 329599 and 331265. " If they are using an alternate commercial control with Rea |
| Quantity | 12,592 kits |
| Distribution | Worldwide Distribution - USA (nationwide) and Internationally to 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
| K052789 | TRIAGE BNP TEST FOR BECKMAN COULTER IMMUNOASSAY SYSTEMS, MODEL 98200 Biosite Incorporated, Jan 23, 2006 |