LIAISON 1-84 PTH Assay - Product Usage: is an in vitro recall
LIAISON 1-84 PTH Assay - Product Usage: is an in vitro chemiluminescent immunoassay (CLIA) intended for the quantitative determination of parathyroid…
Why was LIAISON 1-84 PTH Assay - Product Usage: is an in vitro recalled?
Potential for system to produce falsely elevated parathyroid hormone (PTH) results from patient samples.
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?
REF 310630; lot numbers: 134909, 134909A and 134909B; UDI: 08056771600125
- Product
- LIAISON 1-84 PTH Assay - Product Usage: is an in vitro chemiluminescent immunoassay (CLIA) intended for the quantitative determination of parathyroid…
- Recalling firm
- Diasorin Inc.
- Quantity
- 5,895 devices
- Distribution
- Worldwide distribution - US Nationwide in the states of KY, OH, GA, PA, FL and the countries of Canada, Argentina, Bahrain, Bosnia & Herzegovnia, Iraq, Jordan, Morocco, Nepal, Russia, Serbia, Singapore, Taiwan, Thailand, Tunisia, Dubai, Italy, Israel, Brazil, Mexico, Australia, and Bulgaria.
- Recall date
- April 7, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)