Richard-Allan Scientific Company recalls Richard Allan Scientific 10% Neutral Buffered Formalin, Part Number: 53901 and 561201 Item 53901 90ml bottle, 125 per c…

Recall date

June 13, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2351-2016

FDA classification

Class II

Brand / firm

Richard-Allan Scientific Company

Sold / distributed

Distributed in the states of FL, PA, NY, MD, CA, and AZ.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.