Recall Z-3017-2018 ยท JSG Culture Media, Non-Selective And Non-Differential
Remel Inc
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
| Date | Aug 13, 2018 |
| Status | Terminated |
| Reason | Products have intermittently failed performance testing during stability studies with various anaerobic microorganisms. |
| Root cause | Under Investigation by firm |
| Action | 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 wh |
| Quantity | 2730 units |
| Distribution | US, Canada, Singapore |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.