Device Recall Richard Allan Scientific 10 Neutral Buffered Formalin 의 리콜

Recall

74557

Class 2

Z-2351-2016

2016-06-13

Terminated

United States

2016-11-08

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=147901

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.

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.