Remel Inc: Medical Device Recall in 2022 - (Recall #: Z-0334-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

Thermo SCIENTIFIC, Sensititre STP6F, Gram Negative IVD AST

Product Classification:

Class I

Date Initiated: October 20, 2022

Date Posted: December 14, 2022

Recall Number: Z-0334-2023

Event ID: 91104

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.

Status: Terminated

Product Quantity: 2656 units

Code Information:

Lot Numbers: B2314, B2174, B2036, B1346, B1183, B1115, B1027

Distribution Pattern:

US Nationwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated