ThermoScientific Oxoid Antimicrobial Susceptibility Discs Recalled for Out-of-Specification Performance
Remel Inc. is recalling certain lots of ThermoScientific Oxoid Antimicrobial Susceptibility Discs because they were manufactured out of specification, potentially affecting laboratory test accuracy. The recall involves 327 units distributed nationwide and to Bermuda.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II device recalled for quality performance issues with no reported illnesses or injuries. This is a voluntary, precautionary recall initiated by the firm due to out-of-specification manufacturing.
Plain-English summary
Remel Inc. is recalling certain lots of ThermoScientific Oxoid Antimicrobial Susceptibility Discs (Model CT0223B), laboratory devices used in clinical microbiology to assess bacterial susceptibility to antibiotics. The affected lot numbers are 2341375, 2343397, 2394162, 2403210, 2438023, 2463120, 2408058, 2438086, 2457651, 2832507, 2840771, 2935065, 2958576, 2968037, and 2978564. The recall involves 327 units distributed worldwide.
The discs were manufactured out of specification, failing to meet required performance standards. Out-of-specification discs could potentially compromise the accuracy of antimicrobial susceptibility test results.
Distribution was nationwide across all U.S. states, the District of Columbia, Hawaii, Puerto Rico, and Bermuda. The recall was initiated voluntarily by Remel Inc. on June 18, 2021, and was classified as FDA Class II. The recall was terminated on August 4, 2023.
The recalled product
- Product
- ThermoScientific Oxoid Antimicrobial Susceptibility Discs Rx only Made in the United Kingdom
- Manufacturer
- Remel Inc
- Affected units
- 327
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 (14)
- Model: CT0223B Lots#'s: 2341375
- 2343397
- 2394162
- 2403210
- 2438023
- 2463120
- 2408058
- 2438086
- 2457651
- 2832507
- 2840771
- 2935065
- 2958576
- 2968037 and 2978564 UDI-DI: 05032384006533
Distribution
Related recalls
Same manufacturer · Remel Inc
See all →- HighGC Agar Base Culture Media Reduced Recovery of Neisseria gonorrhoeae
FDA (Devices) · 2026-07-08
- HighYeastone Broth recalled because it may report incorrect susceptibility results
FDA (Devices) · 2026-04-22
- SevereRemel Campy CVA Medium Lot Recalled Over Low Pathogen Recovery
FDA (Devices) · 2026-03-04
- ModerateCulture media recalled over contamination that may darken the broth
FDA (Devices) · 2025-12-03
- HighStrep Selective II Agar plates may carry Listeria monocytogenes contamination
FDA (Devices) · 2025-08-06
Same hazard · quality defect
See all →- LowSupernus Recalls Trokendi XR Topiramate Capsules for Dissolution Failure
FDA (Drugs) · 2026-09-09
- ModerateDicyclomine Hydrochloride Capsules Recalled for Empty Capsules
FDA (Drugs) · 2026-08-12
- ModerateMethohexital Sodium for Injection Recalled for Failed Impurities and Degradation Specifications
FDA (Drugs) · 2026-07-15
- ModerateMedline Circumcision Trays recalled due to Lidocaine quality issues
FDA (Devices) · 2026-07-08
- ModerateMedline Convenience Kits Block Tray recalled due to quality defects
FDA (Devices) · 2026-07-08
Similar recalls
- ModerateRemel Recalls Oxoid Aztreonam Antimicrobial Susceptibility Test Discs
FDA (Devices) · 2013-02-13
- ModerateRemel Recalls Oxoid Antimicrobial Susceptibility Testing Discs Due to Impregnation Defect
FDA (Devices) · 2014-01-22
- SevereRemel Recalls Gentamicin Antimicrobial Susceptibility Testing Discs
FDA (Devices) · 2015-12-23
- ModerateRemel Recalls Oxoid Vancomycin Susceptibility Discs Due to Impregnation Defect
FDA (Devices) · 2014-03-26
- ModerateRemel Recalls Oxoid Cefpodoxime Antimicrobial Susceptibility Test Discs
FDA (Devices) · 2014-01-29
- ModerateRemel Recalls Oxoid Cefoxitin Antimicrobial Susceptibility Discs Due to Insufficient Dose
FDA (Devices) · 2013-02-20