Recall Z-0538-2014 ยท JTO Discs, Strips And Reagents, Microorganism Differentiation
Remel Inc
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
| Date | Dec 18, 2013 (initiated May 2, 2013) |
| Status | Terminated |
| Reason | The product may give weak or false negative test results. |
| Root cause | Process control |
| Action | ThermoFisher sent a Medical Device Recall letter dated April 26, 2013, or May 2, 2013, to all affected customers via first class mail. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to notify any personnel who need to be notified of the potential for a false negative test result, review their inventory for affected product lots and discard the affected product. Customers were also instructed to return the attached Medical Device Recall Return Response acknowledging the disposal of the affected product. Customers with qu |
| Quantity | 109 kits |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K842828 | STREPTEX ZL01 Wellcome Diagnostics, Aug 15, 1984 |