Recall Z-0332-2023— Remel Inc
Class I · Terminated
Class I FDA medical device recall by Remel Inc, initiated 2022-10-20, terminated 2024-09-30. It names 6 FDA 510(k) clearances: K073424, K060621, K983244 and 3 more. Product: Thermo SCIENTIFIC, Sensititre CMC7AFLF, Gram Negative IVD AST. 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..
- Recalling firm
- Remel Inc
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2022-10-20
- Terminated
- 2024-09-30
- Firm location
- Lenexa, KS, United States
510(k) clearances named in this recall
6 on FDA's record- K073424 — SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES
- K060621 — SUSCEPTIBILITY TEST PLATE FOR ERTAPENEM 0.002-16UG/ML FOR GRAM NEGATIVE. SUSCEPTIBILITY TEST PLATE FOR ERTAPENEM 0.015-
- K983244 — SENSITITRE 18-24 HR SUSCEPTIBILITY PLATES(ADDITION OF MEROPENEM)
- K936305 — SENSITITRE/PIP/TA2 SUSCEPTIBILITY PLATES
- K880641 — SENSITITRE STABILITY PLATES
- K860753 — SENSITITRE SUSCEPTIBILITY PLATES
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Thermo SCIENTIFIC, Sensititre CMC7AFLF, Gram Negative IVD AST
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.