Richard Allan Scientific 10% Neutral Buffered Formalin — Class II medical device recall Z-2351-2016
Terminated recall by Richard-Allan Scientific Company, reported 2016-08-17, distributed in AZ, CA, FL, MD, NY, PA. potential contamination with potassium hydroxide may have an impact when performing immunohistochemistry testi
| Recall number | Z-2351-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Richard-Allan Scientific Company, Kalamazoo, MI, United States |
| Recall initiated | 2016-06-13 |
| Classified | 2016-08-05 |
| Reported by FDA | 2016-08-17 |
| Terminated | 2016-11-08 |
| Distributed | AZ, CA, FL, MD, NY, PA |
| Quantity | 18 cases |
| Lot numbers | 371348, 371355 |
| Model numbers | 53901, 561201 |
| Expiration dates | 2020-04-01 |
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2351-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.