Recall Z-0331-2023 ยท JWY Manual Antimicrobial Susceptibility Test Systems
Remel Inc
Thermo SCIENTIFIC, Sensititre CMC5VGNF, Gram Negative IVD AST
| Date | Dec 8, 2022 (initiated Oct 20, 2022) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Process control |
| Action | 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 ema |
| Quantity | 588 units |
| Distribution | US Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K060621 | SUSCEPTIBILITY TEST PLATE FOR ERTAPENEM 0.002-16UG/ML FOR GRAM NEGATIVE. SUSCEPTIBILITY TEST PLATE FOR ERTAPENEM 0.015- Tds Holdings, Inc., Apr 21, 2006 |
| K073424 | SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES Trek Diagnostic Systems, Inc., Jan 22, 2008 |
| K860753 | SENSITITRE SUSCEPTIBILITY PLATES Gibco Laboratories Life Technologies, Inc., May 6, 1986 |
| K880641 | SENSITITRE STABILITY PLATES Sensititre , Ltd., May 13, 1988 |
| K936305 | SENSITITRE/PIP/TA2 SUSCEPTIBILITY PLATES Radiometer America, Inc., Jul 13, 1995 |
| K983244 | SENSITITRE 18-24 HR SUSCEPTIBILITY PLATES(ADDITION OF MEROPENEM) Trek Diagnostic Systems, Inc., Nov 30, 1998 |