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Richard-Allan Scientific Company recalls Richard Allan Scientific 10% Neutral Buffered Formalin, Part Number: 53901 and 561201 Item 53901 90ml bottle, 125 per
Recalled August 17, 2016 · FDA recall Z-2351-2016 · Richard-Allan Scientific
Hazard
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. · FDA Class II
Units
18 cases
Sold at
Distributed in the states of FL, PA, NY, MD, CA, and AZ.
Description
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.
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.
Manufacturer(s)
Richard-Allan Scientific Company
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →