FDA Enforcement
Class II
Terminated
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: Z-0537-2014
·
Reported December 25, 2013
Enforcement
- Recall Number
- Z-0537-2014
- Event ID
- 65476
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Remel Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- December 25, 2013
- Initiation Date
- May 2, 2013
- Classification Date
- December 18, 2013
- Termination Date
- March 12, 2014
- Address
- 12076 Santa Fe Trail Dr, N/A, Lenexa, KS, 66215-3519, United States
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.
Reason
The product may give weak or false negative test results.
Code Info
Lot 1192181, exp. January 2014
Distribution
Nationwide Distribution
Quantity
768 kits