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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* 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
Recall Number Z-0538-2014
Classification Class II
Code Info Lot 1149576, exp January 2014
Product Distributed Qty 109 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