The Recall Desk

FDA (Devices) recall action 71614

Remel Inc recalled 2 products on 2015-08-19

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2015-08-19
Critical
0
Units
6,279

Why these products were recalled

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

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–2 of 2

  • ModerateFDA (Devices)··2015-08-19

    Remel Recalls PathoDx Strep B Grouping Latex Reagent

    Remel Inc is recalling PathoDx Strep B Grouping Latex because a reagent may cause weak reactions, potentially leading to failure to identify target species.

    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.
    Category
    Distribution
    1 state
  • HighFDA (Devices)··2015-08-19

    Remel Recalls PathoDx Strep Grouping Kits Due to Reagent Issues

    Remel Inc is recalling 1,859 PathoDx Strep Grouping Kits because a reagent may cause weak reactions, potentially leading to failure to identify target species.

    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.
    Category
    Distribution
    1 state