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.
Reported: August 19, 2015 Initiated: June 30, 2015 #Z-2351-2015
Product Description
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.
Reason for Recall
A reagent present may produce weak or slow reactions; continued use may result in a failure to identify target species.
Details
- Recalling Firm
- Remel Inc
- Units Affected
- 4420 bottles
- Distribution
- Nationwide Distribution, including Puerto Rico and the country of Canada.
- Location
- Lenexa, KS
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Remel Inc. Units affected: 4420 bottles.
Why was this product recalled? ▼
A reagent present may produce weak or slow reactions; continued use may result in a failure to identify target species.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 19, 2015. Severity: Moderate. Recall number: Z-2351-2015.
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