ETEST OXACILLIN OX 256 US F100 In vitro diagnostic recall
ETEST OXACILLIN OX 256 US F100 In vitro diagnostic, a quantitative technique for determining the antimicrobial susceptibility of bacteria species.
Why was ETEST OXACILLIN OX 256 US F100 In vitro diagnostic recalled?
QC failures (MIC out of range high) for S.aureus ATCC 29213 strain on ETEST OX 256 (OXACILLIN) Foam packaging (Ref. 520558, 520518) reported. The product behavior could lead to False Resistant results.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
REF: 520558, Lot numbers: 1003059010, 1003315830, 1004071250, 1004818860 and 1004890400.
- Product
- ETEST OXACILLIN OX 256 US F100 In vitro diagnostic, a quantitative technique for determining the antimicrobial susceptibility of bacteria species.
- Recalling firm
- BioMerieux SA
- Quantity
- 1585 units
- Distribution
- Worldwide Distribution - USA (nationwide) and to the countries of : Algeria, Austria, Australia, Belarus, Bosnia-Herz., Canada, Croatia, Czech Republic, Egypt, Estonia, France, Georgia, Germany, Greece, Guam, Hong Kong, Hungary, India, Israel, Italy, Japan, Kuwait, Lebanon, Malta, Mexico, Netherlands, Nigeria, Peru, Philippines, Qatar, Russian Fed., Saudi Arabia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, Turkey, United Kingdom and Utd.Arab Emir.
- Recall date
- December 27, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)