Recall Z-2351-2015 ยท GTY Antigens, All Groups, Streptococcus Spp.
Remel Inc
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.
| Date | Aug 7, 2015 (initiated Jun 30, 2015) |
| Status | Terminated |
| Reason | A reagent present may produce weak or slow reactions; continued use may result in a failure to identify target species. |
| Root cause | Under Investigation by firm |
| Action | On 4/28/2015, the recalling firm's European subsidiary notified the recalling firm of the recall. On 6/30/2015, the recalling firm notified their customers of the recall via letter, sent USPS standard mail. |
| Quantity | 4420 bottles |
| Distribution | Nationwide Distribution, including Puerto Rico and the country of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.