Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

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 Recall Z-2351-2015 · Posted 2015-08-07

Recalling FirmRemel Inc
Recall StatusTerminated
Product CodeGTY
Date Initiated2015-06-30
Date Terminated2017-02-13
Product Quantity4420 bottles

Reason for Recall

A reagent present may produce weak or slow reactions; continued use may result in a failure to identify target species.

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.

Root Cause

Under Investigation by firm

Distribution Pattern

Nationwide Distribution, including Puerto Rico and the country of Canada.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑