Recall record at a glance
| Official record | Z-1540-2014 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Alere San Diego, Inc. |
| Report date | May 14, 2014 |
| Recall initiation date | Mar 20, 2014 |
| Quantity | 12,592 kits |
| Location | San Diego, CA, United States |
Official product description
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, and for the risk stratification of patients with heart failure.
Why the product was recalled
These lots may not recover within range when tested using certain commercially available controls.
Distribution information
Worldwide Distribution - USA (nationwide) and Internationally to Australia, Canada, China, EU, Mexico, Russia, Singapore, South Africa, South Korea, Taiwan and United Arab Emirates.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
FDA source limitation: openFDA enforcement reports are a reference dataset, not a live public-alert or recall-lifecycle service. FDA notes that enforcement-report status may not be updated after classification. Confirm current actions with the FDA, recalling firm or appropriate healthcare professional when relevant.