Levofloxacin Antimicrobial Susceptibility Discs Recalled Due to Packaging Mislabeling
Oxoid Limited is recalling 1,406 units of Lev5 Levofloxacin susceptibility discs because packaging may contain Norfloxacin discs instead, which could affect laboratory test results.
What this means for you
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 medical device recall with mislabeling that could affect diagnostic test results. While no illnesses or injuries have been reported, the hazard involves potential for incorrect laboratory results that could impact clinical decision-making, fitting the rubric criterion of 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Oxoid Limited is recalling Lev5 Levofloxacin susceptibility discs (REF CT1587B, lot 6142394). These in vitro diagnostic medical devices are used for antimicrobial susceptibility testing in laboratory settings.
The discs are being recalled because packaging labeled as containing Levofloxacin 5 µg susceptibility discs may actually contain Norfloxacin susceptibility discs instead. This mislabeling could result in incorrect antimicrobial susceptibility test results if the wrong disc is used for testing.
The affected units (1,406 total) were distributed to laboratories in the United States (California, Florida, Massachusetts, Nebraska, New Hampshire, Virginia, and Washington) and internationally including Austria, Australia, Brazil, Canada, China, Costa Rica, France, Germany, Ghana, Hong Kong, Indonesia, Netherlands, Peru, Philippines, Poland, South Korea, Spain, and the United Kingdom.
The recalled product
- Product
- Lev5, REF CT1587B, 50 Susceptibility discs Levofloxacin 5 ug, IVD, CE 2797
- Manufacturer
- Oxoid Limited
- Hazard
- mislabeling
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)
- Lot # 6142394/UDI: 5032384079629
Distribution
Distributed in 7 states:
- CA
- FL
- MA
- NE
- NH
- VA
- WA
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