Company: Beckman Coulter Inc.
Date of Enforcement Report: 5/29/2019
Class I
PRODUCT
UniCel DxH 900 Coulter Cellular Analysis System, REF number C11478
Product Usage: Note: The DxH 900 hematology analyzer is CLIA categorized under document CR180294 and is currently marketed as a member of the instrument family of the DxH 800 cleared under K140911, per FDA s guidance, Guidance for Industry and FDA Staff, Replacement Reagent and Instrument Family Policy . DxH 800 intended use states: The UniCel¿ DxH 800 Analyzer is a quantitative multi-parameter, automated hematology analyzer for in vitro diagnostic use in screening patient populations found in clinical laboratories. The UniCel DxH 800 Analyzer identifies and enumerates the parameters indicated below on the following sample types: Whole Blood (Venous and Capillary) o WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW, RDW-SD, PLT, MPV, NE%, NE#, LY%, LY#, MO%, MO#, EO%, EO#, BA%, BA#, NRBC%, NRBC#, RET%, RET#, MRV, IRF Pre-Diluted Whole Blood (Venous and Capillary) o WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW, RDW-SD, PLT, MPV Body Fluids (cerebrospinal, serous and synovial) or TNC and RBC
Recall Number: Z-1384-2019
REASON
Unexpected elevated platelet levels are possibly erroneous results due to device failure.
RECALLING FIRM/MANUFACTURER
Beckman Coulter Inc. on 7/30/2018. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
341
DISTRIBUTION
US Nationwide and International