Trucount Absolute Count Tubes/Counting Control Beads

• • Terminated Z-2252-2016 FDA Class II ·initiated 24 Jun 2016

  One lot of BD Trucount Absolute Counting Tubes (IVD) may not be sealed properly and exposure to ambient environment can rapidly degrade the performance of the product.

• • Terminated Z-1570-2016 FDA Class II ·initiated 31 Mar 2016

  One lot of lot of BD Trucount tubes may contain tubes from another lot. There is a 3.3% difference in bead counts between the two lots found within some of the pouches and presents a low risk to patient safety or impact to data if this product is used.

510(k) Number

K970836 ↗

FDA Product Code

GKZ

Device Class

Class II

Regulation

21 CFR Part 864.5220

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

• Tritest CD3 Fitc/CD19 Pe/CD45 Percp Reagent with Trucount Absolute Count Tubes

  Class II

  FDA 510(k) K970742 Active Cleared 22 Oct 1997

• Bd Facs 7-Color Setup Beads Open recall

  Class II

  FDA 510(k) K040026 Active Cleared 10 Sep 2004

• Bd Facscanto System

  Class II

  FDA 510(k) K040725 Active Cleared 10 Sep 2004

• Multitest CD3/CD8/CD45/CD4

  Class II

  FDA 510(k) K974360 Active Cleared 11 Mar 1998

• Simultest CD3/Anti-Hla-Dr

  Class II

  FDA 510(k) K924587 Active Cleared 5 Aug 1993

• Tritest Reagent CD3 Fitc/CD4 Pe/CD45 Percp; Trucount Absolute Count Tubes

  Class II

  FDA 510(k) K965053 Active Cleared 21 Nov 1997

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