FDA recall Z-3019-2018
Remel Inc · Class II · device
Product
remel THIOGLYCOLLATE MEDIUM, REF 05152
Reason for recall
Products have intermittently failed performance testing during stability studies with various anaerobic microorganisms.
Distribution
US, Canada, Singapore
Key facts
- Status
- Terminated
- Initiation date
- 2018-08-13
- Report date
- 2018-09-19
- Termination date
- 2019-06-18
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Lenexa, KS, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3019-2018