Recall Class: Class I
Date Recall Initiated: September 17, 2014
Products: 10% Neutral Buffered Formalin. Product codes, product names, lot numbers, and expiration dates are included in the table below.
All other lots not included the table below, or similar products manufactured by Richard-Allan Scientific, are not affected by this recall.
- Manufacturing Date: July 18, 2014, Distribution Dates: July 18 - September 17, 2014
Use: 10% neutral buffered Formalin is a liquid chemical used to preserve human tissue samples. These tissues are later examined for changes that could be caused by specific conditions or diseases, including cancer. The primary users of this solution are doctors’ offices, clinics, hospital emergency departments, and operating rooms.
Richard-Allan Scientific, subsidiary of Thermo Fisher Scientific
4481 Campus Drive
Kalamazoo, Michigan 49008
Reason for Recall: Richard-Allan Scientific discovered that the defective products returned from several customers were found to have from 0% to 3% Formalin content instead of the required 10%. A too-low or too high concentration of Formalin will not properly preserve or can damage tissues.
Use of this defective Formalin may prevent or delay diagnoses and treatment decisions. The long-range health impact can include death or disability from a disease, such as cancer, that was not correctly diagnosed or treated, or an injury from using a treatment that may not have been needed.
Should you have any questions about this recall, please contact Richard-Allan Scientific product support at 1-800-522-7270, option 2, Monday - Friday, 8 a.m. to 5 p.m., Eastern Time.
FDA District: Detroit District Office
More Information about this Recall:
Richard-Allan Scientific sent an Urgent Medical Device Recall letter dated September 10, 2014 to all customers followed by a second letter dated October 3, 2014 with additional information.
The firm sent a follow-up letter dated October 10, 2014 that recommended attending physicians of all patients that could be affected be contacted in order to determine if further testing is required for their patients.
Richard-Allan advises customers/users to:
- Immediately stop using the defective product.
- Upon identifying the defective lots, notify Richard-Allan Scientific of the quantity and the preferred disposal/return method.
- If the defective product is being disposed of, evidence of disposal is required to be sent to Richard-Allan Scientific.
- If the defective product has been used with no issues, notify Richard-Allan Scientific of the quantity that is unavailable for return or disposal.
- Immediately complete and return the acknowledgement form that is attached to the Urgent Medical Device Recall letter.
|Product Code||Product Name||Lot Number||Expiration Date|
|534801||Richard-Allan Scientific Specimen Transportation System||296986||July 2018|
|59601||Richard-Allan Scientific Bio-Tite Specimen Containers||300233||July 2018|
|51401||Richard-Allan Scientific 10% Neutral Buffered Formalin||300649||June 2018|
|53151||Richard-Allan Scientific Specimen Transportation System||300143||July 2018|
|426-796||Protocol 10% NBF||298987||July 2018|
|C4320-450B||Cardinal Health Prefilled Buffered 10% Formalin||300403||July 2018|
|LC-0060||Richard-Allan Scientific 10% Neutral Buffered Formalin||300445||July 2018|
About Class I Recalls
Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX.