Beckman Coulter Inc. recalls UniCel DxH 900 Coulter Cellular Analysis System, REF number C11478 Product Usage: Note: The DxH 900 hematology analyzer…

Recall date

July 30, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1384-2019

FDA classification

Class I

Brand / firm

Beckman Coulter Inc.

Sold / distributed

Worldwide Distribution - US Nationwide including Puerto Rico. There was government and military distribution. Foreign distribution was made to Andorra, Australia, Austria, Belgium, Canada, China, Croatia, Egypt, France, Germany, Greece, Hungary, India, Israel, Italy, Japan, Korea, Kuwait, Latvia, L…

Why it was recalled

Complaints received of sporadic erroneously elevated platelet results without flags or system messages. Thrombocytopenia may go unrecognized.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

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) o TNC and RBC