Company:Bd Diagnostic Systems Tripath
Date of Enforcement Report 3/25/2009
Class:ll
PRODUCT
BD PrepStain System, Model Number: 799-14000-00; Catalog Number: 05CR000021, 05CR00021R, 799-13000-00, 799-13000-00R, 799-14000-00 and 799-14000-00R; Catalog Number: 05CR000021, 05CR000021R, 799-13000-00, 799-13000-00R, 799-14000-00 and 7914000-00R. PrepStain is a liquid-based thin layer cell preparation device for preparation and staining of Prep smear slides from cervical specimens in a liquid based format (gyn use) and of cytology examination slides from non-cervical specimens such as urine and lung lavage, Recall # Z-1090-2009
REASON
Software Error in the non-gyn program of some devices may cause non-gyn samples to be incorrectly transferred from centrifuge tubes to slides potentially resulting in mismatched patient results.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Bd Diagnostic Systems Tripath, Durham, NC, by telephone on September 26, 2008 and by letter on September 29, 2008.
Manufacturer: Bd Diagnostics, Burlington, NC. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
662 units
DISTRIBUTION
Nationwide and Internationally
