Sensititre STP6F diagnostic plates may report false antibiotic susceptibility results
Remel's Sensititre STP6F diagnostic plates may produce false susceptible results for Gram-negative bacteria when tested with certain antibiotics, potentially leading to inappropriate 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: FDA Class I designation requires a minimum severity score of 4. The recall involves potential false diagnostic results that could lead to inappropriate antimicrobial therapy. However, no illnesses or injuries have been reported, so the classification is Severe rather than Critical.
Plain-English summary
Remel Inc is recalling 2656 units of Thermo Scientific Sensititre STP6F diagnostic susceptibility testing plates nationwide. An internal investigation confirmed that the plates may produce false susceptibility results when testing certain Gram-negative bacteria (Proteus species, Providencia species, and Morganella morganii) with seven specific antibiotics: doripenem, ertapenem, meropenem, imipenem, cefepime, piperacillin/tazobactam, and aztreonam.
These diagnostic plates are used in clinical laboratories to determine antibiotic resistance patterns. False susceptibility results—indicating bacteria are treatable with certain antibiotics when they may be resistant—can lead to inappropriate antibiotic selection and reduced treatment effectiveness.
The affected plates were distributed nationwide. Affected lot numbers are B2314, B2174, B2036, B1346, B1183, B1115, and B1027. Clinical laboratories should immediately discontinue use of these lots, review recent test results from affected batches, and contact Remel Inc for replacement products and further guidance.
The recalled product
- Product
- Thermo SCIENTIFIC, Sensititre STP6F, Gram Negative IVD AST
- Manufacturer
- Remel Inc
- Affected units
- 2,656
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 (7)
- Lot Numbers: B2314
- B2174
- B2036
- B1346
- B1183
- B1115
- B1027
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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