Richard Allan Scientific Recalls 10% Neutral Buffered Formalin Due to Contamination
Richard-Allan Scientific Company is recalling 18 cases of 10% Neutral Buffered Formalin due to potential potassium hydroxide contamination that may affect immunohistochemistry test results.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source text explicitly states that the potential for false test results 'may lead to serious injury,' which aligns with the rubric criterion for Severe (4) involving significant injury reports or risks.
Plain-English summary
Richard-Allan Scientific Company is recalling 18 cases of 10% Neutral Buffered Formalin, Part Numbers 53901 and 561201. The recall is due to potential contamination with potassium hydroxide. The affected lots are 371348 and 371355, both with an expiration date of 01APR2020.
The contamination may impact immunohistochemistry testing by affecting tissue antigenicity. If tissue antigenicity is affected, there is a risk of false positive or false negative test results, which may lead to serious injury. Patients may need to be re-biopsied as a result of these potential errors.
The product was distributed in the states of Florida, Pennsylvania, New York, Maryland, California, and Arizona. Users of the product should stop using it and contact the manufacturer for instructions.
The recalled product
- 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.
- Manufacturer
- Richard-Allan Scientific Company
- Affected units
- 18
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- Item 53901
- Lot 371348
- exp date 01APR2020
- Item 561201
- Lot 371355
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