Reported Aug 17, 2016 · Terminated

Richard Allan Scientific 10% Neutral Buffered Formalin, Part Number: 53901 and 561201 Item 53901 90ml bottle, 125 per…

Richard-Allan Scientific Company

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Richard-Allan Scientific Company · 4481 Campus Dr · Kalamazoo, MI · 49008-2590

Is this the product you have?

  • 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
Lot codes and dates
    • Item 53901
    • Lot 371348
    • exp date 01APR2020
    • Item 561201
    • Lot 371355
    • exp date 01APR2020
Amount recalled
18 cases

Where it was sold

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Nov 8, 2016 · Data as of Sep 19, 6:05 PM UTC

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