CLASS II ONGOING Device recall · Reported 12 Feb 2025 · FDA Enforcement Report
Lev5, REF CT1587B, 50 Susceptibility discs Levofloxacin recalled
Oxoid is recalling Lev5, REF CT1587B, 50 Susceptibility discs Levofloxacin 5 ug, IVD, CE, distributed in 7 states. The recall was initiated on 23 Dec 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1075-2025
- FDA event ID
- 96113
- Recalling firm
- Oxoid, Basingstoke
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 23 Dec 2024
- FDA classified
- 4 Feb 2025
- Reported
- 12 Feb 2025
- Type
- Voluntary: Firm initiated
- Reason category
- Labeling Errors
- Device type
- Other Medical Devices
Timeline
| 23 Dec 2024 | Recall initiated by company | |
| 4 Feb 2025 | Classified by FDA | +43 days |
| 12 Feb 2025 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Mislabeling; Levofloxacin Antimicrobial susceptibility disc packaging may contain Norfloxacin Antimicrobial Susceptibility discs.
Product as listed by the FDA
Lev5, REF CT1587B, 50 Susceptibility discs Levofloxacin 5 ug, IVD, CE 2797
Where it was distributed
US: VA, CA, NE, MA, FL, CA, MA, NH, WA OUS: Austria, Australia, Brazil, Canada, China, Costa Rica, Germany, Spain, France, United Kingdom, Ghana, Hong Kong, South Korea, Netherlands, Peru, Philippines, Poland, Indonesia
CaliforniaFloridaMassachusettsNebraskaNew HampshireVirginiaWashington
Questions about this recall
Why was it recalled?
Mislabeling; Levofloxacin Antimicrobial susceptibility disc packaging may contain Norfloxacin Antimicrobial Susceptibility discs.
Which lots are affected?
Lot # 6142394/UDI: 5032384079629
Where was it sold?
US: VA, CA, NE, MA, FL, CA, MA, NH, WA OUS: Austria, Australia, Brazil, Canada, China, Costa Rica, Germany, Spain, France, United Kingdom, Ghana, Hong Kong, South Korea, Netherlands, Peru, Philippines, Poland, Indonesia
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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