Medical Device Recall: Sensititre GN6F May Report False Antibiotic Susceptibility Results
The FDA recalled Sensititre GN6F Gram Negative antimicrobial susceptibility test plates (2,471 units) because they may report false results indicating bacteria are susceptible to certain antibiotics when they are actually resistant.
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: FDA Class I medical device recall. No deaths or serious injuries are reported in the source, so the severity score is Severe (4) rather than Critical (5) per the rubric's Class I criterion.
Plain-English summary
Remel Inc is recalling 2,471 units of the Thermo Scientific Sensititre GN6F Gram Negative In Vitro Diagnostic Antimicrobial Susceptibility Test (AST) plate. The product is distributed nationwide in the United States.
An internal technical investigation confirmed that the plate may produce false susceptible results when Proteae Tribe bacteria (including Proteus spp., Providencia spp., and Morganella morganii) are tested with certain antibiotics. The affected antibiotics are: doripenem, ertapenem, meropenem, imipenem, cefepime, piperacillin/tazobactam, and aztreonam.
False susceptible results indicate that bacteria are susceptible to these antibiotics when they are actually resistant. The affected lot numbers are B2247, B2096, B1445, B1263, B1176, and B0503A.
The recalled product
- Product
- Thermo SCIENTIFIC, Sensititre GN6F, Gram Negative IVD AST
- Manufacturer
- Remel Inc
- Hazard
- false-susceptible-result
- diagnostic-error
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 (6)
- Lot Numbers: B2247
- B2096
- B1445
- B1263
- B1176
- B0503A
Distribution
Distributed nationwide across the United States.
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