Recall Z-2081-2013— Remel Inc
Class III · Terminated
Class III FDA medical device recall by Remel Inc, initiated 2013-03-25, terminated 2014-06-03. It names one FDA 510(k) clearance: K860153. Product: Oxoid Antimicrobial Susceptibility Test Discs F300 (Nitrofurantoin), Cat. #CT0036B, packaged in cartridges of 50 discs, 5 cartridges/pack. The firm name on the label is Oxoid Ltd., Basingstoke, Hampshire, England Product is used in the semi-quantitative agar diffusion test method for in-vitro susceptibility testing.. Reason: Use of affected lots may give false indication of susceptibility to Nitrofurantoin..
- Recalling firm
- Remel Inc
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2013-03-25
- Terminated
- 2014-06-03
- 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 Antimicrobial Susceptibility Test Discs F300 (Nitrofurantoin), Cat. #CT0036B, packaged in cartridges of 50 discs, 5 cartridges/pack. The firm name on the label is Oxoid Ltd., Basingstoke, Hampshire, England Product is used in the semi-quantitative agar diffusion test method for in-vitro susceptibility testing.
Reason for recall
Use of affected lots may give false indication of susceptibility to Nitrofurantoin.
Data sourced from openFDA. This site is unofficial and independent of the FDA.