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 |
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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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