Oxoid Vancomycin 30 mcg, each cartridge contains 50 susceptibility discs, CT0058B. The firm name on the label is Oxoid L
FDA device recall Z-1246-2014 · posted 2014-03-20 · Terminated
Recall details
- Recalling firm
- Remel Inc
- Reason for recall
- Some of the discs may not be impregnated with the antibiotic.
- Action taken
- ThermoFisher sent an Urgent Medical Device Recall letter dated February 18, 2014, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to notify any personnel who need to be notified of the potential for a false indication of resistance to Vancomycin. Customers were also instructed to review their inventory for the affected product and discard it. Customers should review results reported using this lot and consider retesting and/or seek appropriate expert advice. Return the attached Medical Device Recall Return Response acknowledging receipt of the notice and disposal of the affected product. If product was further distributed, customers should contact those entities, advise them of the situation and provide them with a copy of the letter. Customers with questions were instructed to contact the Technical Services Department at 800-255-6730 (US) and 913-888-0939 (International). For questions regarding this recal lcall 913-895-4185.
- Root cause
- Process control
- Status
- Terminated
- Product code
- JTN
- Quantity affected
- 40/5/50-disc cartridge packages
- Distribution
- Nationwide Distribution
- Date initiated
- 2014-02-18
- Date posted
- 2014-03-20
- Date terminated
- 2014-06-25
- 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 |