Recalls / —
—#138408
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.
- FDA product code
- GTY — Antigens, All Groups, Streptococcus Spp.
- Device class
- Class 1
- Medical specialty
- Microbiology
- Affected lot / code info
- lot 1463129, exp. date 31 May 2016
Why it was recalled
A reagent present may produce weak or slow reactions; continued use may result in a failure to identify target species.
Root cause (FDA determination)
Under Investigation by firm
Action the firm took
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.
Recalling firm
- Firm
- Remel Inc
- Address
- 12076 Santa Fe Trail Dr, Lenexa, Kansas 66215-3519
Distribution
- Distribution pattern
- Nationwide Distribution, including Puerto Rico and the country of Canada.
Timeline
- Recall initiated
- 2015-06-30
- Posted by FDA
- 2015-08-07
- Terminated
- 2017-02-13
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #138408. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.