FDA Medical Device Recalls (openFDA)
BioMerieux SA: ETEST OXACILLIN OX 256 US F100 In vitro diagnostic, a quantitative technique for determining the antimicrobial susceptibility of bacteria species.
- Recall number
- Z-0264-2018
- Recalling firm
- BioMerieux SA
- Product
- ETEST OXACILLIN OX 256 US F100 In vitro diagnostic, a quantitative technique for determining the antimicrobial susceptibility of bacteria species.
- Status
- Terminated
- Initiated
- 2017-04-13
- Posted
- 2017-12-19
- Terminated
- 2020-08-18
- Reason
- 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.
- Root cause
- Under Investigation by firm
- Action
- BioMerieux sent an Urgent Field Safety Notice on April 30, 2017. Short-term Action: Subsidiaries and distributors are required to discard all ETEST OX 256 (OXACILLIN) Foam packaging (Ref. 520558, 520518) under (PSS#3320) remaining in their inventory. In order to avoid any backorders on the field during the transition to the SPB configuration that is conformed to the expected specifications, Subsidiaries and Distributors were instructed to distribute the Urgent Field Safety Notice (customer letter) to inform Medical customers and Veterinary customers that have received and will receive the product. The Urgent Field Safety Notice informed customers of the non-conformity along with instructions to continue the use of the impacted products with recommendations described in customer letter, and in addition, for the Medical Customers, to discuss any concerns they may have regarding previously reported Susceptible results on the impacted batches Listed Table 1 with their Laboratory Medical Director to determine the appropriate course of action. Long-term Action: A CAPA (PR#1101306) has been initiated in order to identify the root-cause and prevent the issue to recur. They were instructed to complete and return the attached Acknowledgement Form by Fax to confirm receipt of this notice. For further questions, please call (314) 731-8694.
- 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.
- Lot, serial or model codes
- REF: 520558, Lot numbers: 1003059010, 1003315830, 1004071250, 1004818860 and 1004890400.
- 510(k) numbers
- ["K913459"]
- PMA numbers
- not on file
- Product code
- JWY
- Firm FEI
- 1000611339
- Firm city
- Marcy L'Etoile
- Firm state
- not on file
- Firm country
- France
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28