Gram-negative antibiotic susceptibility test device recalled for false susceptible results
Sensititre MDRGN3F antibiotic test device may return false susceptible results for certain gram-negative bacteria, risking inappropriate antibiotic treatment. FDA Class I recall issued.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I medical device recall without reported serious injury or death. The device may produce incorrect antibiotic susceptibility test results that could impact clinical treatment decisions.
Plain-English summary
The Sensititre MDRGN3F is an in vitro diagnostic device manufactured by Remel Inc used for antibiotic susceptibility testing of gram-negative bacteria.
An internal technical investigation confirmed the device may produce false susceptible results when testing bacteria from the Proteae Tribe (including Proteus species, Providencia species, and Morganella Morganii) against doripenem, ertapenem, meropenem, imipenem, cefepime, piperacillin/tazobactam, and aztreonam. This means organisms resistant to these antibiotics may be reported as susceptible.
The recall affects 70 units distributed nationwide (lot B2311B).
False susceptible results could lead to inappropriate antibiotic treatment selection, potentially compromising patient outcomes.
The recalled product
- Product
- Thermo SCIENTIFIC, Sensititre MDRGN3F, Gram Negative IVD AST
- Manufacturer
- Remel Inc
- Affected units
- 70
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 (1)
- Lot Numbers: B2311B
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 →Related recalls
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