FDAClass IISeptember 12, 2012

Poly stat Flu A & B Test Manufactured for Polymedco 510 recall

Poly stat Flu A & B Test Manufactured for Polymedco 510 Furnace Dock Road Cortlandt Manor, NY 10567 Tel 800-431-2123 914-739-5400 Fax 914-739-5890.…

Why was Poly stat Flu A & B Test Manufactured for Polymedco 510 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 FLU22 Lot numbers 441A11, 441C11

Product
Poly stat Flu A & B Test Manufactured for Polymedco 510 Furnace Dock Road Cortlandt Manor, NY 10567 Tel 800-431-2123 914-739-5400 Fax 914-739-5890.…
Recalling firm
Princeton Biomeditech Corp
Quantity
103 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)
Open FDA enforcement record Latest recalls