FDA recall Z-0331-2023

Product

Thermo SCIENTIFIC, Sensititre CMC5VGNF, 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.

Distribution

US Nationwide Distribution

Key facts

Status

Terminated

Initiation date

2022-10-20

Report date

2022-12-14

Termination date

2024-09-30

Voluntary/Mandated

Voluntary: Firm initiated

Location

Lenexa, KS, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0331-2023