Remel Inc recalls Streptex* kit, Ref R30950501 ZL50, Rapid latex test for Streptococcal grouping, IVD. The kit contains reagent groups A,

Recalled December 25, 2013 · FDA recall Z-0537-2014 · Remel

Hazard

The product may give weak or false negative test results. · FDA Class II

Units

768 kits

Sold at

Nationwide Distribution

Description

The product may give weak or false negative test results.

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 system for use in the qualitative detection and identification of the Lancefield group of streptococci. Reagents are provided for groups A, B, C, D, F and G covering the majority of clinical isolates, group E streptococci are rarely isolated.

Manufacturer(s)

Remel Inc

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →