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U.S. Department of Health and Human Services

Class 2 Device Recall Remel, Haemophilus Test Medium

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  Class 2 Device Recall Remel, Haemophilus Test Medium see related information
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
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
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
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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