Alere Triage BNP Calibrators for the Beckman Coulter recall
Alere Triage BNP Calibrators for the Beckman Coulter Access Family of Immunoassay Systems, Model No. 98202 The Alere Triage BNP test is intended for…
Why was Alere Triage BNP Calibrators for the Beckman Coulter recalled?
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.
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?
Lot #328163
- Product
- Alere Triage BNP Calibrators for the Beckman Coulter Access Family of Immunoassay Systems, Model No. 98202 The Alere Triage BNP test is intended for…
- Recalling firm
- Alere San Diego, Inc.
- 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.
- Recall date
- July 2, 2014
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (device)