Becton, Dickinson and Company, BD Bio Sciences: BD Trucount Controls, 30 Test - REF: 664343, RxOnly, IVD

Hazard

Control kits contain incorrect standard deviation (SD) values for the low and high control beads which compromises the accurate calculation of bead counts.

Details from the source

Reason for recall: Control kits contain incorrect standard deviation (SD) values for the low and high control beads which compromises the accurate calculation of bead counts. Distribution: Worldwide - US Nationwide distribution in the states of Tennessee, New York, Massachusetts and the countries of Argentina, Belgium, Botswana, Brazil, Canada, France, Germany, Lithuania, Peru, Philippines, United Kingdom. Quantity: 10 kits Lot/code info: Lot: 4285713/UDI: 00382906643438

UPC codes

00382906643438

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.