Recall Z-2126-2017 ยท JWY Manual Antimicrobial Susceptibility Test Systems
BioMerieux SA
Ceftriaxone TX 32 US S30, Ref 412302 and Ceftriaxone TX 32 US F100, Ref 507058 ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic ba
| Date | May 3, 2017 (initiated Jan 1, 2017) |
| Status | Terminated |
| Reason | Potential performance issue on strain categorization. |
| Root cause | Other |
| Action | Biomerieux sent an Urgent Field Safety Notice dated January 2017, to Laboratory Manager or Laboratory Director. The Notice indicated what actions to take and included a reply form to be returned. Required actions: The following recommendations require your immediate attention to ensure the product will continue to perform per its labeled performance specifications, within its revised shelf-life of twelve (12) months. Product with NO remaining shelf life (after reduction): Identify impacted lots of ETEST Ceftriaxone TXL32 (Ref. 412302, 412303) (lots listed in Table 1 below) which are now e |
| Quantity | 4656 kits |
| Distribution | USA (nationwide) Distribution to the states of : AZ, AR, CA, CT, DE, FL, GA, HI, IL, LA, ME, MA, MI, MN, MO, MT, NH, NY, NC, OR, PA, SC, SD, TN, TX, WA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K945433 | ETEST/CEFTRIAXONE/HAEMOPHILUS/PNEUMOCOCCUS Ab Biodisk, Mar 17, 1995 |