Recall Z-3017-2018— 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 IND. W/ DEXTROSE W/ HEMIN & VIT.K (a) 10ML, REF 07182 (b) 10ML, REF 07180 (c) 5ML, REF 064732 (d) 5ML, REF 064730 (e) 9ML, REF 064720. 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 IND. W/ DEXTROSE W/ HEMIN & VIT.K (a) 10ML, REF 07182 (b) 10ML, REF 07180 (c) 5ML, REF 064732 (d) 5ML, REF 064730 (e) 9ML, REF 064720
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.