PathoDx Strep B Grouping Latex recall
PathoDx Strep B Grouping Latex, REF 62031, 3 ml packaged in plastic dropper bottle with a pink cap. Latex reagent for streptococcal group B; Identify beta-hemolytic streptococci of Lancefield Groups A, B, C, F and G from primary culture plates.
Why was PathoDx Strep B Grouping Latex 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 1463129, exp. date 31 May 2016
- Product
- PathoDx Strep B Grouping Latex, REF 62031, 3 ml packaged in plastic dropper bottle with a pink cap. Latex reagent for streptococcal group B; Identify beta-hemolytic streptococci of Lancefield Groups A, B, C, F and G from primary culture plates.
- Recalling firm
- Remel Inc
- Quantity
- 4420 bottles
- Distribution
- Nationwide Distribution, including Puerto Rico and the country of Canada.
- Recall date
- August 19, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)