FDAFDA · Food and drugs·Recall number 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.
Published December 25, 2013 · Recall initiated: May 2, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The product may give weak or false negative test results.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Remel Inc
- Distributor
- Nationwide Distribution
- Lot
- Lot 1192181, exp. January 2014
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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