—#138407

Product

PathoDx Strep Grouping Kit, REF 62025, packaged 60 tests per kit. Latex agglutination test for identification of beta-hemolytic streptococci of Lancefield Groups A, B, C, F or 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 1470133, exp. date 31 Mar 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 #138407. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.