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GUIDANCE DOCUMENT

Errors and Accidents Regarding Saline Dilution of Samples Used for Viral Marker Testing Guidance for Industry June 1998

Final
Issued by:
Guidance Issuing Office
Center for Biologics Evaluation and Research

Inspections by Food and Drug Administration (FDA) personnel have identified instances in which the integrity of samples intended to be used for viral marker testing has been compromised by saline during collection of blood and blood components with automated pheresis instruments when the saline reinfusion protocol was utilized. FDA has noted instances where samples for testing were diluted by saline as a result of three separate problems. These problems involved inadvertent keypad entries that caused the tubing to be rinsed with saline during sample collection, improper installation of tubing into a valve clamp, or failure to clamp the saline line that caused saline to be added to the collection bag during collection. The use of saline diluted samples is potentially significant in that it could contribute to obtaining false negative results for viral marker testing, and result in the transfusion or further manufacture of potentially infectious blood and blood products.


Submit Comments

Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All comments should be identified with the title of the guidance.

Questions?

Contact Point
Office of Communication, Outreach and Development (OCOD)
Center for Biologics Evaluation and Research
Food and Drug Administration
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Silver Spring, MD 20993-0002
ocod@fda.hhs.gov
(800) 835-4709
(240) 402-8010