FDA Medical Device · Z-0537-2014

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.

Class II · Terminated

The product may give weak or false negative test results.

Affected lots / codes — check yours against thisLot 1192181, exp. January 2014

Recalling firm: Remel Inc, Lenexa, KS
Classification: Class II (temporary or reversible harm possible)
Status: Terminated
Quantity: 768 kits
Distribution: Nationwide Distribution
Recall initiated: May 2, 2013
Classified: December 18, 2013
Terminated: March 12, 2014
Initiation: Voluntary: Firm initiated

Official source. This record is published by the U.S. FDA through the openFDA enforcement database. View the unmodified government record:
https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0537-2014%22

Important. Recalls target specific lots and codes — compare the affected lots above against your own product. This page reproduces public FDA data for readability; EveryRecall is independent and not affiliated with the FDA.

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