| Class 2 Device Recall remel THIOGLYCOLLATE MEDIUM W/O IND. W/ DEXTROSE W/ HEMIN & VIT.K10ML | |
Date Initiated by Firm | August 13, 2018 |
Create Date | September 07, 2018 |
Recall Status1 |
Terminated 3 on June 18, 2019 |
Recall Number | Z-3018-2018 |
Recall Event ID |
80813 |
Product Classification |
Culture media, non-selective and non-differential - Product Code JSG
|
Product | remel THIOGLYCOLLATE MEDIUM W/O INDICATOR. W/ DEXTROSE
(a) 9ML, REF 064700
(b) 10ML, REF 07176
(c) 9ML, REF 064702 |
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 |
Recalling Firm/ Manufacturer |
Remel Inc 12076 Santa Fe Trail Dr Lenexa KS 66215-3519
|
For Additional Information Contact | 913-895-4077 |
Manufacturer Reason for Recall | Products have intermittently failed performance testing during stability studies with various anaerobic microorganisms. |
FDA Determined Cause 2 | 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 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). |
Quantity in Commerce | 384 units |
Distribution | US, Canada, Singapore |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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