Recall Z-3018-2018— Remel Inc
Class II · Terminated
Class II FDA medical device recall by Remel Inc, initiated 2018-08-13, terminated 2019-06-18. FDA's recall record names no specific 510(k) clearance for this event. Product: remel THIOGLYCOLLATE MEDIUM W/O INDICATOR. W/ DEXTROSE (a) 9ML, REF 064700 (b) 10ML, REF 07176 (c) 9ML, REF 064702. Reason: Products have intermittently failed performance testing during stability studies with various anaerobic microorganisms..
- Recalling firm
- Remel Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-08-13
- Terminated
- 2019-06-18
- Firm location
- Lenexa, KS, United States
Product description
remel THIOGLYCOLLATE MEDIUM W/O INDICATOR. W/ DEXTROSE (a) 9ML, REF 064700 (b) 10ML, REF 07176 (c) 9ML, REF 064702
Reason for recall
Products have intermittently failed performance testing during stability studies with various anaerobic microorganisms.
Data sourced from openFDA. This site is unofficial and independent of the FDA.