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
Reported: December 25, 2013 Initiated: May 2, 2013 #Z-0538-2014
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
Reason for Recall
The product may give weak or false negative test results.
Details
- Recalling Firm
- Remel Inc
- Units Affected
- 109 kits
- Distribution
- Nationwide Distribution
- Location
- Lenexa, KS
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Remel Inc. Units affected: 109 kits.
Why was this product recalled? ▼
The product may give weak or false negative test results.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 25, 2013. Severity: Moderate. Recall number: Z-0538-2014.
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