Device product
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
Z-0538-2014
Product summary
- Firm
- Remel Inc
- Event
- Event 65476
- Status
- Terminated
- Classification
- Class II
- Quantity
- 109 kits
- Official record key
device-enforcement:Z-0538-2014
Official wording
Reason: The product may give weak or false negative test results.
Code information: Lot 1149576, exp January 2014
Distribution pattern: Nationwide Distribution
Derived failure modes
-
Unknown
The product may give weak or false negative test results.