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U.S. Department of Health and Human Services

Enforcement Report - Week of December 26, 2013

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Product Detail

Product Description 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.
Recall Number Z-0537-2014
Classification Class II
Code Info Lot 1192181, exp. January 2014
Product Distributed Qty 768 kits
Reason For Recall The product may give weak or false negative test results.

Event Detail

Event Id 65476
Product Type Devices
Status Completed
Recalling Firm Remel Inc
City Lenexa
State KS
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-05-02
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide Distribution