Device product
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.
Z-0537-2014
Product summary
- Firm
- Remel Inc
- Event
- Event 65476
- Status
- Terminated
- Classification
- Class II
- Quantity
- 768 kits
- Official record key
device-enforcement:Z-0537-2014
Official wording
Reason: The product may give weak or false negative test results.
Code information: Lot 1192181, exp. January 2014
Distribution pattern: Nationwide Distribution
Derived failure modes
-
Unknown
The product may give weak or false negative test results.