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.
What this means for you
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
- Hazard
- quality-defect
- testing-inaccuracy
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
Distributed nationwide across the United States.
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