Z-2351-2016 Class II Terminated
FDA device recall Z-2351-2016 was initiated by Richard-Allan Scientific Company on June 13, 2016 and is designated Class II. 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 t… The recall status is terminated (terminated November 8, 2016). Affected quantity: 18 cases.
Recall Details
- Product Type
- Devices
- Report Date
- August 17, 2016
- Initiation Date
- June 13, 2016
- Termination Date
- November 8, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 18 cases
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.
Distribution Pattern
Distributed in the states of FL, PA, NY, MD, CA, and AZ.
Code Information
Item 53901, Lot 371348, exp date 01APR2020; Item 561201, Lot 371355, exp date 01APR2020