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Recall Observatory FDA recall evidence

Device 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.

Z-2351-2016

June 13, 2016

Class II

Product summary

Firm
Richard-Allan Scientific Company
Event
Event 74557
Status
Terminated
Classification
Class II
Quantity
18 cases
Official record key
device-enforcement:Z-2351-2016

Official wording

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.

Code information: Item 53901, Lot 371348, exp date 01APR2020; Item 561201, Lot 371355, exp date 01APR2020

Distribution pattern: Distributed in the states of FL, PA, NY, MD, CA, and AZ.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.