Inappropriate hepatitis test kit

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Record number: 
MPHO Type: 
Estimated frequency: 
Not identified
Time to detection: 
2 years
Alerting signals, symptoms, evidence of occurrence: 
The correct test kit was used previously for shared organ/tissue donors but an unannounced switch was made by the hospital testing laboratory and not identified for two years. This change from a "donor screening test" to a "diagnostic test" kit was eventually identified by the tissue bank during an audit of the testing lab.
Demonstration of imputability or root cause: 
This was a tissue bank initiated, voluntary recall that was eventually classified by US FDA as "Class III" which is "a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences." (see This recall involved more than 32,000 allografts distributed over a few years nationwide, including Puerto Rico and St. Thomas, Virgin Islands. Other countries included: South Korea, Venezuela, Canada, the Netherlands, Jamaica, El Salvador, Colombia, Switzerland, Dominican Republic, Greece, Australia, Trinidad, W.I. Saudi Arabia, San Jose, and Guam.
Imputability grade: 
3 Definite/Certain/Proven
Groups audience: 
Suggest references: 
See FDA's posting for "Enforcement Reports":
Expert comments for publication: 
No transmission of disease was reported as the result of this event. The event demonstrates the importance of the need for a well written agreement, contract, or memorandum of understanding between the tissue bank and each infectious disease testing laboratory that performs testing for donors of tissue. Expectations should include an annual audit of the laboratory and an understanding of FDA's test requirements for donors of human cells, tissues and cellular and tissue-based products (HCT/Ps).