FDAClass IIAugust 19, 2015

PathoDx Strep Grouping Kit recall

PathoDx Strep Grouping Kit, REF 62025, packaged 60 tests per kit. Latex agglutination test for identification of beta-hemolytic streptococci of…

Why was PathoDx Strep Grouping Kit recalled?

A reagent present may produce weak or slow reactions; continued use may result in a failure to identify target species.

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?

lot 1470133, exp. date 31 Mar 2016

Product
PathoDx Strep Grouping Kit, REF 62025, packaged 60 tests per kit. Latex agglutination test for identification of beta-hemolytic streptococci of…
Recalling firm
Remel Inc
Quantity
1859 kits
Distribution
Nationwide Distribution, including Puerto Rico and the country of Canada.
Recall date
August 19, 2015
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls