Recall Z-0443-2016— Remel Inc
Class II · Terminated
Class II FDA medical device recall by Remel Inc, initiated 2015-11-06, terminated 2017-02-13. It names one FDA 510(k) clearance: K860153. Product: Oxoid Gentamicin Antimicrobial Susceptibility Testing Disc (CN10), REF# CT0024B packaged in packs of 5 cartridges - 50 disc/cartridge. Used in the semi-quantitative agar diffusion test method for in vitro susceptibility testing to assist in the determination of a suitable antibiotic agent for treatment purposes.. Reason: Antibiotic concentration may be insufficient which may result in incorrect test results..
- Recalling firm
- Remel Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-11-06
- Terminated
- 2017-02-13
- Firm location
- Lenexa, KS, United States
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
Oxoid Gentamicin Antimicrobial Susceptibility Testing Disc (CN10), REF# CT0024B packaged in packs of 5 cartridges - 50 disc/cartridge. Used in the semi-quantitative agar diffusion test method for in vitro susceptibility testing to assist in the determination of a suitable antibiotic agent for treatment purposes.
Reason for recall
Antibiotic concentration may be insufficient which may result in incorrect test results.
Data sourced from openFDA. This site is unofficial and independent of the FDA.