| Class 2 Device Recall Remel, Haemophilus Test Medium | |
Date Initiated by Firm | February 09, 2017 |
Create Date | March 03, 2017 |
Recall Status1 |
Terminated 3 on May 01, 2019 |
Recall Number | Z-1400-2017 |
Recall Event ID |
76445 |
Product Classification |
Culture media, antimicrobial susceptibility test - Product Code LKA
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Product | Remel, Haemophilus Test Medium (Agar) in A) 100 mm REF R01503, and B) 150 mm plates REF R04033, |
Code Information |
A) Lot: 978596, 2017-01-30; B) Lot: 978948, 2017/01/30 |
Recalling Firm/ Manufacturer |
Remel Inc 12076 Santa Fe Trail Dr Lenexa KS 66215-3519
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For Additional Information Contact | Gary Klaassen 913-895-4077 |
Manufacturer Reason for Recall | Test organisms exhibit poor growth when grown using the test agar. The poor growth can give users incorrect AST zones when performing susceptibility tests. |
FDA Determined Cause 2 | Nonconforming Material/Component |
Action | Thermo Fisher sent an Urgent Medical Device Recall letter dated February 9, 2017, to all affected customers. The recalling firm issued written notifications to their customers. Customers were instructed to destroy any remaining inventory of the recalled lots. Customers were also instructed to contact everyone within their organization or any other organization where the devices have been transferred. An acknowledgement form was included with the recall notice. Customers were asked to complete the acknowledgement form and return it to the recalling firm.
If you have any questions, please contact our Technical Service Department at (800) 255-6730 ( US ) or (913) 888-0939 ( International)
For further questions, please call (913) 895-4077. |
Quantity in Commerce | RO4033 - 163, R01503 - 50. |
Distribution | USA ( nationwide ) Distribution including Puerto Rico and to the states of : AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, RI, SD, TN, TX, VA, VT, WA, WI, WV and WY. |
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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