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.
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. 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
- Affected units
- 2,471
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.
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.
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