Recall Z-0722-2022 · JWY Manual Antimicrobial Susceptibility Test Systems
Remel Inc
Thermo Scientific Sensititre Gram Negative Susceptibility Testing Plate, IVD format
| Date | Jan 10, 2022 |
| Status | Terminated |
| Reason | There are lower than expected MICs for some gram negative species. |
| Root cause | Under Investigation by firm |
| Action | A customer letter was issued to impacted consignees on or around 01/10/2022. Customers are asked to check for affected product and the recalling firm requests that customers do not report results of cefiderocol when affected product is used with Thermo Scientific Mueller-Hinton Broth with TES, catalong T3462, lots 267261 to 402775. Consignees are asked to disseminate the recall information within their organization and to any other organization to which affected products have been transferred. An acknowledgement form should be submitted by email to MBD.vigilance@thermofisher.com. |
| Quantity | 1210 devices |
| Distribution | Distribution throughout the United States. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K193538 | Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Cefiderocol in the dilution range of 0.03-64 µg/ml Thermo Fisher Scientific, Mar 12, 2020 |