Recall Z-2351-2015
Remel Inc · initiated June 30, 2015
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: lot 1463129, exp. date 31 May 2016
Reason for recall
A reagent present may produce weak or slow reactions; continued use may result in a failure to identify target species.
FDA-determined cause: Under Investigation by firm
Action taken
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.
Details
- Recall number
- Z-2351-2015
- Initiated
- June 30, 2015
- Posted by FDA
- August 7, 2015
- Terminated
- February 13, 2017
- Product code
- GTY – Antigens, All Groups, Streptococcus Spp.
- Quantity
- 4420 bottles
- Distribution
- Nationwide Distribution, including Puerto Rico and the country of Canada.
- Recalling firm
- Remel Inc, Lenexa, KS
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2350-2015 Class II | PathoDx Strep Grouping Kit, REF 62025, packaged 60 tests per kit. Latex agglutination…A reagent present may produce weak or slow reactions; continued use may result in a failure to identify… | 06/30/2015Terminated |