Oxoid Antimicrobial Susceptibility Test Discs F300 (Nitrofurantoin), Cat. #CT0036B, packaged in cartridges of 50 discs,
FDA device recall Z-2081-2013 · posted 2013-08-26 · Terminated
Recall details
- Recalling firm
- Remel Inc
- Reason for recall
- Use of affected lots may give false indication of susceptibility to Nitrofurantoin.
- Action taken
- ThermoFisher sent an Medical Device Recall letter dated March 18, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Please notify any personnel who needs notified of the potential for a false indication of susceptibility to Nitrofurantoin. Please review your inventory for affected product lots and discard the affected product. Return the attached Medical Device Recall Return Response acknowledging the disposal of the affected product. If you have any questions, please contact our Technical Services Department at 800-255-6730 (US) or 913- 888-0939 (International).
- Root cause
- Unknown/Undetermined by firm
- Status
- Terminated
- Product code
- JTN
- Quantity affected
- 60 packs
- Distribution
- US Distribution including the states of AL, AR, CA, FL, GA, IL, KS, LA, MA, MD, NY, OK, PA, RI, TX, VA, and WA.
- Date initiated
- 2013-03-25
- Date posted
- 2013-08-26
- Date terminated
- 2014-06-03
- Location
- Lenexa, KS
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| OXOID ANTIMICROBIAL SUSCEPTIBILITY DISCS (K860153) | Oxoid U.S.A., Inc. | 1986-03-04 |