Yeastone Broth, 11ML, 10/BOX, used in antibiotic susceptibility testing of mycological clinical specimens
Remel, Inc · Affected lot did not meet specifications. Product may report false susceptibility to antifungal agents, specifically within the Azole family.
Open FDA's page for this record- Cfres ID
- 223399
- Product res number
- Z-0355-2027
- Event date initiated
- 2026-10-19
- Event date posted
- 2026-11-03
- Recall status
- Open, Classified
- Res event number
- 100139
- Product code
- NGZ
- Product description
- Yeastone Broth, 11ML, 10/BOX, used in antibiotic susceptibility testing of mycological clinical specimens
- Code info
- YY3462 lot 440400 UDI-DI 848838018817
- Firm FEI number
- 1924669
- Recalling firm
- Remel, Inc
- Address 1
- 12076 Santa Fe Trail Dr
- City
- Lenexa
- State
- KS
- Postal code
- 66215-3519
- Additional info contact
- Erica Knox 800-255-6730
- Reason for recall
- Affected lot did not meet specifications. Product may report false susceptibility to antifungal agents, specifically within the Azole family.
- Root cause description
- Under Investigation by firm
- Product quantity
- 33 US, 54 OUS
- Distribution pattern
- Worldwide - US Nationwide distribution in the states of MA and CA. The countries of India, Saudi Arabia, UK.
- Action
The firm began notifying affected customers on October 19, 2026. Customers were instructed to notify any personnel who needed to be aware of the issue. Customers should review previously reported susceptibility results generated using the affected lot and assess whether retesting is appropriate. Customers should destroy any remaining inventory of the affected lot. Do not use it for any clinical laboratory testing. Customers should complete and return the acknowledgement form accompanying the letter. Firm will replace product or issue credit. If you have any questions, please contact our Technical Services Department at 800-255-6730 (US) or email microbiology.ts.us@thermofisher.com. You should complete the accompanying Acknowledgment Form upon receipt and return to MBD.vigilance@thermofisher.com
- K numbers
- K090968
- Harmonized identifiers (openFDA)
- Device name
- Susceptibility Test Plate, Antifungal
- Medical specialty description
- Microbiology
- Regulation number
- 866.1640
- Device class
- 2
- K number
- K133817, K040560, K232967, K211539, K221198, K232963, K243738, K181368, K061945, K133952, K101566, K151817, K082534, K231433, K221899, K081063, K151923, K092454, K991810, K090968, K133038
- Registration number
- 3013718871, 1950204, 9615754, 3031977134
- FEI number
- 3013718871, 1950204, 3031977134, 3008237827