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 bottle125 per caseItem 561201 120ml bottle75 per case
- Lot codes and dates
Item 53901Lot 371348exp date 01APR2020Item 561201Lot 371355exp 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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