FDA Medical Device Recalls (openFDA)
Richard-Allan Scientific Company: 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 number
- Z-2351-2016
- Recalling firm
- Richard-Allan Scientific Company
- 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.
- Status
- Terminated
- Initiated
- 2016-06-13
- Posted
- not on file
- Terminated
- 2016-11-08
- Reason
- 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
- 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
- 18 cases
- Distribution
- Distributed in the states of FL, PA, NY, MD, CA, and AZ.
- Lot, serial or model codes
- Item 53901, Lot 371348, exp date 01APR2020; Item 561201, Lot 371355, exp date 01APR2020
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- IFP
- Firm FEI
- 1831638
- Firm city
- Kalamazoo
- Firm state
- MI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28