Thermo SCIENTIFIC, Sensititre GN6F, Gram Negative IVD AST
FDA device recall Z-0328-2023 · posted 2022-12-08 · Terminated
Recall details
- Recalling firm
- Remel Inc
- Reason for recall
- An internal technical investigation has confirmed that Thermo Scientific" Gram Negative IVD AST Sensititre Plate may lead to false susceptible results for Proteae Tribe (including Proteus spp., Providencia spp., Morganella Morganii) when tested with doripenem, ertapenem, meropenem, imipenem, cefepime, piperacillin/tazobactam and aztreonam.
- Action taken
- The firm issued an "Urgent Medical Device Correction" notice to its consignees on 10/25/2022 by US mail. The notice explained the issue, risk to health, and notified the consignees of an update to the IFU, specifically, "to add limitations for Carbapenems (Imipenem, Doripenem, Meropenem, Ertapenem), Cefepime, Piperacillin/Tazobactam and Aztreonam added for users to "NOT REPORT" any result for each member of the Protea tribe (including Proteus spp., Providencia spp., Morganella Morganii) to address false susceptible results." Please complete and return the Required Customer Reply form via email to MBD.vigilance@thermofisher.com. Please keep this notification on file. The notice needs to be passed on to all who need to be aware within your organization or to any organization where the potentially affected products have been transferred. This correction notification is being made and performed by the US agent, Remel Inc., on behalf of the Foreign Manufacturer of the affected product, Trek Diagnostic Systems Ltd., located in East Grinstead, UK. Trek Diagnostic Systems and Remel Inc., both part of Thermo Fisher Scientific, are investigating the root cause and will implement corrective actions to prevent future recurrence. If you have any questions, please contact our Technical Services Department at 800-255-6730 (US) or email microbiology.ts.us@thermofisher.com.
- Root cause
- Process control
- Status
- Terminated
- Product code
- JWY
- Quantity affected
- 2471 units
- Distribution
- US Nationwide Distribution
- Date initiated
- 2022-10-20
- Date posted
- 2022-12-08
- Date terminated
- 2024-09-30
- Location
- Lenexa, KS
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES (K073424) | Trek Diagnostic Systems, Inc. | 2008-01-22 |
| SUSCEPTIBILITY TEST PLATE FOR ERTAPENEM 0.002-16UG/ML FOR GRAM NEGATIVE. SUSCEPTIBILITY TEST PLATE FOR ERTAPENEM 0.015- (K060621) | Tds Holdings, Inc. | 2006-04-21 |
| SENSITITRE 18-24 HR SUSCEPTIBILITY PLATES(ADDITION OF MEROPENEM) (K983244) | Trek Diagnostic Systems, Inc. | 1998-11-30 |
| SENSITITRE/PIP/TA2 SUSCEPTIBILITY PLATES (K936305) | Radiometer America, Inc. | 1995-07-13 |
| SENSITITRE STABILITY PLATES (K880641) | Sensititre , Ltd. | 1988-05-13 |
| SENSITITRE SUSCEPTIBILITY PLATES (K860753) | Gibco Laboratories Life Technologies, Inc. | 1986-05-06 |