Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Richard Allan Scientific 10% Neutral Buffered Formalin Recalled by Richard-Allan Scientific Company Due to potential contamination with potassium hydroxide may have an...

Date: June 13, 2016
Company: Richard-Allan Scientific Company
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Richard-Allan Scientific Company directly.

Affected Products

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.

Quantity: 18 cases

Why Was This 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.

Where Was This Sold?

This product was distributed to 6 states: AZ, CA, FL, MD, NY, PA

Affected (6 states)Not affected

About Richard-Allan Scientific Company

Richard-Allan Scientific Company has 14 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report