Richard Allan Scientific 10% Neutral Buffered Formalin recall: Contamination
Richard Allan Scientific 10% Neutral Buffered Formalin, Part Number: 53901 and 561201 Item 53901 90ml bottle, 125 per case; Item 561201 120ml bottle…
Why was Richard Allan Scientific 10% Neutral Buffered Formalin 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Item 53901, Lot 371348, exp date 01APR2020; Item 561201, Lot 371355, exp date 01APR2020
- Product
- Richard Allan Scientific 10% Neutral Buffered Formalin, Part Number: 53901 and 561201 Item 53901 90ml bottle, 125 per case; Item 561201 120ml bottle…
- Recalling firm
- Richard-Allan Scientific Company
- Quantity
- 18 cases
- Distribution
- Distributed in the states of FL, PA, NY, MD, CA, and AZ.
- Recall date
- August 17, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)