25

Mar

2009

Cl Il BD PrepStain System

0

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

About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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