Alere Triage BNP Test for the Beckman Coulter Access recall
Alere Triage BNP Test for the Beckman Coulter Access Family of Immunoassay Systems, Model Number 98200, Lot Numbers: 329599, 331265. The Alere Triage…
Why was Alere Triage BNP Test for the Beckman Coulter Access recalled?
These lots may not recover within range when tested using certain commercially available controls.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Model Number: 98200. Lot/Unit Codes: Lot #329599, K329599 (Distributed OUS), 331265 and K331265 (Distributed OUS). Expiration date, or Expected shelf life: 10/31/14 and 12/31/14
- Product
- Alere Triage BNP Test for the Beckman Coulter Access Family of Immunoassay Systems, Model Number 98200, Lot Numbers: 329599, 331265. The Alere Triage…
- Recalling firm
- Alere San Diego, Inc.
- 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.
- Recall date
- May 14, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)