Recall Z-0441-2016— Biomerieux
Class I · Terminated
Class I FDA medical device recall by Biomerieux, initiated 2015-11-19, terminated 2017-06-19. It names one FDA 510(k) clearance: K953223. Product: Etest¿ PIP/TAZO/CON-4 PTC 256 - Foam of 100 tests WW. Etest¿ is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria.. Reason: Due to the potential for reporting erroneous results for Piperacillin/Tazobactam; specifically false susceptible results..
- Recalling firm
- Biomerieux
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2015-11-19
- Terminated
- 2017-06-19
- Firm location
- Letoile, 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¿ PIP/TAZO/CON-4 PTC 256 - Foam of 100 tests WW. Etest¿ is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria.
Reason for recall
Due to the potential for reporting erroneous results for Piperacillin/Tazobactam; specifically false susceptible results.
Data sourced from openFDA. This site is unofficial and independent of the FDA.