Recall Z-2351-2015— Remel Inc
Class II · Terminated
Class II FDA medical device recall by Remel Inc, initiated 2015-06-30, terminated 2017-02-13. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: A reagent present may produce weak or slow reactions; continued use may result in a failure to identify target species..
- Recalling firm
- Remel Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-06-30
- Terminated
- 2017-02-13
- Firm location
- Lenexa, KS, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.