Z-2351-2016Class II

Richard Allan Scientific 10% Neutral Buffered Formalin, Part Number: 53901 and 561201 Item 53901 90ml bottle...

Name: Z-2351-2016 Richard Allan Scientific 10% Neutral Buffered Formalin, Part Number: 53901 and 561201 Item 53901 90ml bottle...
Creator: Richard-Allan Scientific Company
Published: 2016-06-13
License: https://open.fda.gov/license/

Richard-Allan Scientific LLC / initiated 2016-06-13 / Terminated / root cause: manufacturing process

FDA source

Richard-Allan Scientific Company began a recall of 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... on 2016-06-13. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2351-2016
Classification: Class II
Status: Terminated
Initiated: 2016-06-13
Posted: 2016-08-05
Terminated: 2016-11-08
Recalling firm: Richard-Allan Scientific LLC
Product: 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 code: IFP Formalin, Neutral Buffered
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
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.
Quantity in commerce: 18 cases
Distribution: Distributed in the states of FL, PA, NY, MD, CA, and AZ.
Product codes and lots: Item 53901, Lot 371348, exp date 01APR2020; Item 561201, Lot 371355, exp date 01APR2020

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2351-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2351-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-17	2016-08-05

Product code IFP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)