The Recall Desk

FDA (Devices) recall action 65476

Remel Inc recalled 2 products on 2013-12-25

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
2013-12-25
Critical
0
Units
877

Why these products were recalled

The product may give weak or false negative test results.

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.

1–2 of 2

  • HighFDA (Devices)··2013-12-25

    Remel Inc. Recalls Streptex Latex D Reagent for False Negative Results

    Remel Inc. is recalling 109 kits of Streptex Latex D reagent because the product may produce weak or false negative test results for streptococcal group D.

    Product
    Streptex* Latex D, Ref R30950901 ZL54, IVD, Latex reagent for streptococcal group D, 50 tests per box. The firm name on the label is Remel Inc., Lenexa, KS, Manufactured by Remel Europe Ltd., Dartford Kent, UK. Streptex is a rapid latex test system for use in the qualitative de
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2013-12-25

    Remel Inc Recalls Streptex Kits Due to Potential False Negative Results

    Remel Inc is recalling 768 Streptex kits because they may produce weak or false negative test results for Streptococcal grouping.

    Product
    Streptex* kit, Ref R30950501 ZL50, Rapid latex test for Streptococcal grouping, IVD. The kit contains reagent groups A, B, C, D, F, G, a control, and an extraction enzyme. The firm name on the label is Remel Europe Ltd., Dartford, England. Streptex is a rapid latex test syst
    Category
    Distribution
    0 states