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Remel Inc recalls Streptex* Latex D, Ref R30950901 ZL54, IVD, Latex reagent for streptococcal group D, 50 tests per box. The firm name on
Recalled December 25, 2013 · FDA recall Z-0538-2014 · Remel
Hazard
The product may give weak or false negative test results. · FDA Class II
Units
109 kits
Sold at
Nationwide Distribution
Description
The product may give weak or false negative test results.
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 detection and identification of the Lancefield group of streptococci
Manufacturer(s)
Remel Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →