Oxoid Antimicrobial Susceptibility Test Discs, CTO425B Ciprofloxacin CIP 5 mcg, 50 discs per cartridge, 5 cartridges per
FDA device recall Z-0528-2014 · posted 2013-12-17 · Terminated
Recall details
- Recalling firm
- Remel Inc
- Reason for recall
- Boxes labeled as CIP5 may contain cartridges of AMP5.
- Action taken
- Thermo Fisher sent a Field Safety Notice dated November 13, 2012, to all affected customers. The letter identified the product, the problem and the action to be taken by the customer. Customers were instructed to check stocks of the affected product if necessary and contact Customer Service or their local Oxoid supplier who will issue a replacement. The notice should be passed on to all who need to be aware within their organization. Customers were also instructed to discard any product labeled as AMP5. For questions, customers were instructed to call +44 (0)1256 841144.discard any product labeled AMP5. For questions regarding this recall call 913-895-4185.
- Root cause
- Mixed-up of materials/components
- Status
- Terminated
- Product code
- JTN
- Quantity affected
- 60/5/50-disc cartridge boxes
- Distribution
- Nationwide Distribution including AL, CA, CO, FL, IA, KS, LA, MA, MS, NE, NH, NJ, NY, OK, OR, RI, TN, TX, VA, WA WI, and Puerto Rico.
- Date initiated
- 2012-11-21
- Date posted
- 2013-12-17
- Date terminated
- 2014-03-12
- Location
- Lenexa, KS
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| OXOID ANTIMICROBIAL SUSCEPTIBILITY DISCS (K860153) | Oxoid U.S.A., Inc. | 1986-03-04 |