Sensititre GN7F Antibiotic Test Plates Recalled for Inaccurate Susceptibility Results
Remel Inc. recalled 8,073 units of Sensititre GN7F antibiotic susceptibility test plates after discovering they may report false results for certain bacteria, potentially leading to incorrect antibiotic treatment decisions.
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: This FDA Class I medical device recall carries a minimum severity of Severe per federal classification requirements. The inaccurate test results could directly impact clinical antibiotic treatment decisions, with no illnesses, injuries, or deaths reported in the source material.
Plain-English summary
Remel Inc. is recalling 8,073 units of Thermo Scientific Sensititre GN7F Gram Negative In Vitro Diagnostic (IVD) Antibiotic Susceptibility Test plates distributed across the United States. These laboratory devices are used to determine bacterial susceptibility to antibiotics and guide antibiotic treatment decisions.
An internal technical investigation confirmed that the test plates may produce inaccurate results when testing certain bacteria from the Proteus family—including Proteus spp., Providencia spp., and Morganella morganii—against seven specific antibiotics: doripenem, ertapenem, meropenem, imipenem, cefepime, piperacillin/tazobactam, and aztreonam. Specifically, the tests may report false susceptible results, indicating that bacteria are susceptible to these antibiotics when they may actually be resistant.
This inaccuracy could lead clinical laboratories to report incorrect test results affecting patient treatment decisions. The recall affects 16 specific lot numbers: B2317, B2267, B2251, B2177, B2086, B2037, B2034B, B1476, B1424, B1384, B1286, B1215, B1182, B1104, B1051, and B1021. Clinical laboratories should review testing records from these lot numbers, particularly for Proteus family organisms.
The recalled product
- Product
- Thermo SCIENTIFIC, Sensititre GN7F, Gram Negative IVD AST
- Manufacturer
- Remel Inc
- Hazard
- Affected units
- 8,073
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 (16)
- Lot Numbers: B2317
- B2267
- B2251
- B2177
- B2086
- B2037
- B2034B
- B1476
- B1424
- B1384
- B1286
- B1215
- B1182
- B1104
- B1051
- B1021
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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