Diagnostic Testing Plates Recalled for Inaccurate Antibiotic Susceptibility Results
Remel Inc is recalling 1210 Thermo Sensititre Gram Negative Testing Plates due to inaccurate susceptibility results that could affect antibiotic resistance testing.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II recall of diagnostic testing plates with inaccurate susceptibility results that could lead to inappropriate antibiotic selection—a risk-of-harm product. No illnesses or injuries are reported in the source material.
Plain-English summary
Remel Inc is recalling approximately 1210 Thermo Scientific Sensititre Gram Negative Susceptibility Testing Plates (Product Number MDRGN2F) distributed throughout the United States. The plates produce lower-than-expected minimum inhibitory concentrations (MICs) for some gram negative bacterial species.
These testing plates are used in clinical microbiology laboratories to determine bacterial susceptibility to antibiotics. Inaccurate test results could lead laboratories to underestimate antibiotic resistance and potentially select inappropriate antibiotics for patient treatment.
The recall affects the following lots: B1402A (Expiration 2022/Oct05), B1315A (Expiration 2022/Aug06), B1211 (Expiration 2022/May24), B1161A (Expiration 2022/Apr19), B0361 (Expiration 2021/Aug31), and B0164B (Expiration 2021/Apr16). Laboratories that have received affected plates should contact Remel Inc for guidance.
The recalled product
- Product
- Thermo Scientific Sensititre Gram Negative Susceptibility Testing Plate, IVD format
- Manufacturer
- Remel Inc
- Affected units
- 1,210
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)
- Product Number MDRGN2F
Distribution
Distribution scope not specified by the agency.
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