Status Flu A + B Test Manufactured by Princeton Bio recall
Status Flu A + B Test Manufactured by Princeton Bio Meditech Corporation Monmouth Junction, NJ 08852 USA. The BioSign Flu A + B test is an in vitro…
Why was Status Flu A + B Test Manufactured by Princeton Bio 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 36022 Lot numbers 441H11 90 kits (22 tests per kit)
- Product
- Status Flu A + B Test Manufactured by Princeton Bio Meditech Corporation Monmouth Junction, NJ 08852 USA. The BioSign Flu A + B test is an in vitro…
- Recalling firm
- Princeton Biomeditech Corp
- Quantity
- 90 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)