Richard-Allan Scientific Company: Medical Device Recall in 2016 - (Recall #: Z-2351-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: June 13, 2016

Date Posted: August 17, 2016

Recall Number: Z-2351-2016

Event ID: 74557

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.

Status: Terminated

Product Quantity: 18 cases

Code Information:

Item 53901, Lot 371348, exp date 01APR2020; Item 561201, Lot 371355, exp date 01APR2020

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated