Recall Z-0264-2018 ยท JWY Manual Antimicrobial Susceptibility Test Systems
BioMerieux SA
ETEST OXACILLIN OX 256 US F100 In vitro diagnostic, a quantitative technique for determining the antimicrobial susceptibility of bacteria species.
| Date | Dec 19, 2017 (initiated Apr 13, 2017) |
| Status | Terminated |
| 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 pro |
| 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, Netherlan |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K913459 | THE E TEST, MODIFICATION Ab Biodisk, Sep 25, 1991 |