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U.S. Department of Health and Human Services

Class 2 Device Recall Richard Allan Scientific 10 Neutral Buffered Formalin

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  Class 2 Device Recall Richard Allan Scientific 10 Neutral Buffered Formalin see related information
Date Initiated by Firm June 13, 2016
Create Date August 05, 2016
Recall Status1 Terminated 3 on November 08, 2016
Recall Number Z-2351-2016
Recall Event ID 74557
Product Classification Formalin, neutral buffered - Product Code IFP
Product Richard Allan Scientific 10% Neutral Buffered Formalin,
Part Number: 53901 and 561201
Item 53901 90ml bottle, 125 per case;
Item 561201 120ml bottle, 75 per case.
Code Information Item 53901, Lot 371348, exp date 01APR2020; Item 561201, Lot 371355, exp date 01APR2020
Recalling Firm/
Manufacturer		 Richard-Allan Scientific Company
4481 Campus Dr
Kalamazoo MI 49008-2590
For Additional Information Contact Michelle Bowerman
269-544-5625
Manufacturer Reason
for Recall		 potential contamination with potassium hydroxide may have an impact when performing immunohistochemistry testing. It is unknown whether the contamination will affect tissue antigenicity. If it were to affect tissue antigenicity, the outcome would be risk of false positive or false negative test results which may lead to serious injury. There is the possibility the patient may need to be re-biopsied.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action On 6/13/2016, URGENT MEDICAL DEVICE RECALL notifications were sent to the affected customers via certified mail with instructions for identifying and disposing of the affected product. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification.
Quantity in Commerce 18 cases
Distribution Distributed in the states of FL, PA, NY, MD, CA, and AZ.
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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