Modification to Bd Facscanto System with Bd Facscanto Clinical Software

• • Terminated Z-2356-2020 FDA Class II ·initiated 8 Jul 2019

  The recalling firm confirmed that BD FACS Sample Prep Assistant (SPA) II and III users may encounter probes with unacceptable wear prior to reaching the 2500 piercings guideline indicated in the Instructions for Use (IFU). When the probe is worn, particles from the rubber cap are more likely to clog the probe, resulting in blocked or inadequate sample dispense.

• • Terminated Z-2357-2020 FDA Class II ·initiated 8 Jul 2019

  The recalling firm confirmed that SPA II and III users may encounter probes with unacceptable wear prior to reaching the 2500 piercings guideline indicated in the Instructions for Use (IFU). When the probe is worn, particles from the rubber cap are more likely to clog the probe, resulting in blocked or inadequate sample dispense.

• • Terminated Z-1940-2010 FDA Unclassified (pre-2012) ·initiated 19 Feb 2010 ·via K050191, on the same 510(k)

  Samples prepared on the BD SPA II, SN T0076 produced inaccurate sample results due to inaccurate sample dispensed as a result of the cap piercing probe

• • Terminated Z-0526-2008 FDA Unclassified (pre-2012) ·initiated 2 Oct 2007 ·via K050191, on the same 510(k)

  Mixing Performance: SPA II devices manufactured with the affected product motor control board may exhibit suboptimal mixing performance.

Recalls marked "via" name another device cleared under the same FDA submission as this one.

510(k) Number

K050191 ↗

FDA Product Code

PER

Device Class

Class I

Regulation

21 CFR Part 862.2750

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Bd Phoenix Automated Microbiology System-Vancomycin Gram Positive

  Class II

  FDA 510(k) K030677 Active Cleared 1 Apr 2003

• BD Veritor System for the Rapid Detection of Flu A + B CLIA waived kit

  Class II

  FDA 510(k) K152870 Active Cleared 27 Oct 2015

• Bd Phoenix Automated Microbiology System-Pipercillin (Gn) 0.5-128 Ug/Ml

  Class II

  FDA 510(k) K041572 Active Cleared 12 Aug 2004

• Bd Probetec Neisseria Gonorrhoeae (Gc) Qx Amplified DNA Assay

  Class II

  FDA 510(k) K090827 Active Cleared 27 May 2009

• Bd Pen Needle

  Class II

  FDA 510(k) K051899 Active Cleared 13 Sep 2005

• Bd Phoenix Automated Microbiology System, Vancomycin (Strep) 0.0625 -32 Ug/Ml

  Class II

  FDA 510(k) K050745 Active Cleared 29 Apr 2005

See all devices from Becton, Dickinson & Co. →