# FDA recall Z-0331-2023

> **Remel Inc** · Class I · device recall initiated 2022-10-20.

## 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

- **Recall number:** Z-0331-2023
- **Recalling firm:** Remel Inc
- **Classification:** Class I
- **Product type:** device
- **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

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

## Citation

> AI Analytics. FDA recall Z-0331-2023. Retrieved 2026-06-08 from https://api.ai-analytics.org/recall/Z-0331-2023. Source: US FDA. Licensed CC0.

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