remel THIOGLYCOLLATE MEDIUM W/O INDICATOR. W/ DEXTROSE (a) 9ML, REF 064700 (b) 10ML, REF 07176 (c) 9ML, REF 064702
- Company
- Remel Inc
- Recall Initiated
- August 13, 2018
- Terminated
- June 18, 2019
- Recall Number
- Z-3018-2018
- Quantity
- 384 units
- Firm Location
- Lenexa, KS
Reason for Recall
Products have intermittently failed performance testing during stability studies with various anaerobic microorganisms.
Distribution
US, Canada, Singapore
Lot / Code Info
(a) 9ML, REF 064700, Lot numbers: 254751, 259508, 272498 (b) 10ML, REF 07176, Lot numbers: 259521 (c) 9ML, REF 064702, Lot numbers: 274247
Root Cause
Under Investigation by firm
Action Taken
The firm initiated the recall by letter on 08/13/2018. The firm directed the consignee to you inspect their stock and destroy any remaining inventory of the lots listed above and contact Customer Services or your local distributor regarding replacement. They also requested that the consignee review results and laboratory reporting associated with use of the listed lots and consider retesting and/or seek appropriate expert advice for further action. The firm instructed the consignee to further distribute the notice to all who need to be aware within your organization or to any organization where the potentially affected products have been transferred. For questions, please contact Technical Services Department at 800-255-6730 (US) or 913-888-0939 (International).