Recall Z-2351-2016 — 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.
U.S. FDA — Device Enforcement · United States · 2016-06-13 · Class II
⚙AI-assisted, human-edited — this page is drafted with AI from public-source data, then reviewed before publication. How we use AI →
Reported risk: 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.
Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.
ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.