Recall Z-1226-2017— BioMerieux SA
Class II · Terminated
Class II FDA medical device recall by BioMerieux SA, initiated 2017-01-18, terminated 2020-01-30. It names one FDA 510(k) clearance: K990722. Product: ETEST XM256 (Cefuroxime), Foam: 506958-506918; SPB: 412304-412305 ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacterial such as Enterobacteriaceae, Pseudomonas, Staphylococcus and Enterococcus species and fastidious bacteria. Reason: Potential performance issues. False Susceptible result instead of Intermediate and False Intermediate result with certain methods..
- Recalling firm
- BioMerieux SA
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-01-18
- Terminated
- 2020-01-30
- Firm location
- Marcy L'Etoile, N/A, France
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
ETEST XM256 (Cefuroxime), Foam: 506958-506918; SPB: 412304-412305 ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacterial such as Enterobacteriaceae, Pseudomonas, Staphylococcus and Enterococcus species and fastidious bacteria
Reason for recall
Potential performance issues. False Susceptible result instead of Intermediate and False Intermediate result with certain methods.
Data sourced from openFDA. This site is unofficial and independent of the FDA.