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.
FDA Recall Z-2351-2016 · Posted None
Recalling FirmRichard-Allan Scientific Company
Recall StatusTerminated
Product CodeIFP
Date Initiated2016-06-13
Date Terminated2016-11-08
Product Quantity18 cases
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.
Firm 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.
Root Cause
Nonconforming Material/Component
Distribution Pattern
Distributed in the states of FL, PA, NY, MD, CA, and AZ.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.