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Terminated

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 Recall Z-2350-2015 · Posted 2015-08-07

Recalling FirmRemel Inc
Recall StatusTerminated
Product CodeGTY
Date Initiated2015-06-30
Date Terminated2017-02-13
Product Quantity1859 kits

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.

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