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.

Recall Insight

This FDA Devices action (record #Z-2351-2016) was formally reported on August 17, 2016, with the manufacturer initiating the action on June 13, 2016. It is classified under Moderate severity (Class II), with a current status of Terminated. Richard-Allan Scientific Company is listed as the recalling firm, operating out of Kalamazoo, MI. Federal records indicate 18 cases units are affected.

The documented reason for this recall is: 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 ant… Distribution data in the federal record shows the product reached: Distributed in the states of FL, PA, NY, MD, CA, and AZ.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 10 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.