Recall Z-2351-2016— Richard-Allan Scientific Company
Class II · Terminated
Class II FDA medical device recall by Richard-Allan Scientific Company, initiated 2016-06-13, terminated 2016-11-08. FDA's recall record names no specific 510(k) clearance for this event. 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: 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..
- Recalling firm
- Richard-Allan Scientific Company
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-06-13
- Terminated
- 2016-11-08
- Firm location
- Kalamazoo, MI, United States
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.