Alinity m HBV Application Specification File recall
Alinity m HBV Application Specification File (US and CE)
Why was Alinity m HBV Application Specification File recalled?
There is a potential for misquantitation high results of negative samples.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA 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?
List Numbers: 1) 08N47-03A (US); Version 1.00 2) 08N47-01B (CE); Version 2.00 3) 08N47-01C (CE); Version 3.00
- Product
- Alinity m HBV Application Specification File (US and CE)
- Recalling firm
- Abbott Molecular, Inc.
- Distribution
- US consignees - AZ, CA, IL, IN, MA, MI, MO, NH, NJ, NY, OH, SD, TX, and VA OUS consignees - Australia, Austria, Belgium, Brazil, Canada, Columbia, Czech Republic, El Salvador, Estonia, France, Germany, Israel, Italy, Japan, Latvia, Malaysia, Netherlands, New Zealand, Norway, Pakistan, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, United Kingdom, and Vietnam
- Recall date
- April 13, 2022
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)