Device product
remel THIOGLYCOLLATE MEDIUM W/O INDICATOR. W/ DEXTROSE (a) 9ML, REF 064700 (b) 10ML, REF 07176 (c) 9ML, REF 064702
Z-3018-2018
Product summary
- Firm
- Remel Inc
- Event
- Event 80813
- Status
- Terminated
- Classification
- Class II
- Quantity
- 384 units
- Official record key
device-enforcement:Z-3018-2018
Official wording
Reason: Products have intermittently failed performance testing during stability studies with various anaerobic microorganisms.
Code information: (a) 9ML, REF 064700, Lot numbers: 254751, 259508, 272498 (b) 10ML, REF 07176, Lot numbers: 259521 (c) 9ML, REF 064702, Lot numbers: 274247
Distribution pattern: US, Canada, Singapore
Derived failure modes
-
Unknown
Products have intermittently failed performance testing during stability studies with various anaerobic microorganisms.