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U.S. Department of Health and Human Services

Class 1 Device Recall 10 NBF

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  Class 1 Device Recall 10 NBF see related information
Date Initiated by Firm September 17, 2014
Date Posted October 09, 2014
Recall Status1 Terminated 3 on October 27, 2016
Recall Number Z-0012-2015
Recall Event ID 69276
Product Classification Fixative, formalin-containing - Product Code LDY
Product Protocol 10% NBF

Product Usage: 10% NBF is used to store and fixate tissue prior to grossing and histological examination. It is a primary fixative that prevents autolysis (degradation) of tissue.
Code Information Product Code: 426-796 Lot Number: 298987
Recalling Firm/
Manufacturer		 Richard-Allan Scientific Company
4481 Campus Dr
Kalamazoo MI 49008-2590
For Additional Information Contact Sarah Rickert
616-385-4466
Manufacturer Reason
for Recall		 The affected lots could have NBF concentrations that are lower or higher than the desired specifications.
FDA Determined
Cause 2		 Mixed-up of materials/components
Action The firm issued an "URGENT MEDICAL DEVICE RECALL" letter to all affected customers. The notification identified the affected products, reason for voluntary recall, risk to health, actions to be taken, and instructions to complete the attached Acknowledgement Form. For questions, contact Sarah Rickert at 269-544-5628 or sarah.rickert@thermofisher.com.
Quantity in Commerce 175 cases
Distribution Worldwide Distribution-USA (nationwide) including the states of PA, IL, CA, TX, GA, WA, MA, KY, OH, NY, VA, NC, IN, NJ, MN, UT, HI, FL, KS, TN, MO, MI, MD, LA, NM, DE, CO, WV, OR, WI, AZ, SC, IA, and NE and the country of Canada.
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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