The Recall Desk
SevereFDA (Devices)·Z-0331-2023·Announced 2022-12-14

Medical Diagnostic Plate Recalled for False Antibiotic Susceptibility Test Results

Remel Inc is recalling 588 units of the Sensititre Gram Negative IVD AST diagnostic plate due to false susceptible test results for certain bacteria when tested with specific antibiotics. The defect could lead to incorrect treatment decisions.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: This is classified as an FDA Class I recall, which mandates a minimum severity score of 4 (Severe) per the rubric. The defect could lead to false diagnostic results and inappropriate antibiotic treatment decisions, though no illnesses are documented in the source.

Plain-English summary

Remel Inc, a Thermo Scientific subsidiary, is recalling 588 units of the Sensititre CMC5VGNF Gram Negative In Vitro Diagnostic (IVD) Antimicrobial Susceptibility Testing (AST) plate. The affected lot numbers are B2125 and B2115. The product has been distributed nationwide in the United States.

The diagnostic plate may produce false susceptible results for bacteria in the Proteae Tribe, including Proteus spp., Providencia spp., and Morganella morganii, when tested with the following antibiotics: doripenem, ertapenem, meropenem, imipenem, cefepime, piperacillin/tazobactam, and aztreonam. False susceptible results could lead clinicians to believe these bacteria are susceptible to antibiotics when they may not be, potentially resulting in inappropriate treatment decisions.

Laboratories and healthcare facilities using affected lot numbers should discontinue use of the product and contact Remel Inc for guidance on replacement or proper disposition of affected plates.

The recalled product

Product
Thermo SCIENTIFIC, Sensititre CMC5VGNF, Gram Negative IVD AST
Manufacturer
Remel Inc
Category
Medical Device
Hazard
Affected units
588

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot Numbers: B2125
  • B2115

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 9 recalled by Remel Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 9 products in this recall →

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