Orasure QuickFlu Rapid A+B Test Manufactured for recall
Orasure QuickFlu Rapid A+B Test Manufactured for OraSure Technologies, Inc Bethlehem, PA 18015 USA. The BioSign Flu A + B test is an in vitro rapid…
Why was Orasure QuickFlu Rapid A+B Test Manufactured for recalled?
There have been reports of dual positive (Flu A + Flu B positive) results being encountered.
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?
510 k K083746 Catalog Number 1001-0320 - 22 test kits Catalog 1001-0322 - 12 test kits
- Product
- Orasure QuickFlu Rapid A+B Test Manufactured for OraSure Technologies, Inc Bethlehem, PA 18015 USA. The BioSign Flu A + B test is an in vitro rapid…
- Recalling firm
- Princeton Biomeditech Corp
- Quantity
- 370 (12 tests per kit) ;2800 kits (22 tests per kit)
- Distribution
- Nationwide Distribution-including the states of NJ, NY, and PA.
- Recall date
- September 12, 2012
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)