—#172923

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) o TNC and RBC

FDA product code: GKZ — Counter, Differential Cell
Device class: Class 2
Medical specialty: Hematology
510(k) numbers: K140911
Affected lot / code info: All current software versions are impacted

Why it was recalled

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

Root cause (FDA determination)

Software Design Change

Action the firm took

Urgent Medical Device Recall letters, dated July 30, 2018, were sent via email and postal mail on August 1, 2018 (for those customers not on their email notification system). On 05/22/19, second Urgent Medical Device (UMDC) Recall letters, and Important Safety Information notices, dated May 20, 2019 (replacing BEC UMDC letter dated July 30, 2018), were sent via mail and/or phone and/or e-mail informing customers perform the following actions: - Run samples on an instrument not subject to this recall to confirm the platelet results. - If an alternative instrument is not available, use the following quality control measures to aid in identification of discrepant platelet results: a) Perform manual scanning/estimate of platelets on a peripheral smear and compare with instrument results. Note that this method will identify samples with marked to moderate thrombocytopenia but may not identify smaller discrepancies. b) Repeat testing of samples in a workflow configuration may facilitate the identification of discrepancies. If an erroneous result is detected, review results from adjacent samples, i.e., those tested on the instrument both before and after the erroneous result. c) Additional instrument and/or LIS features including reference ranges, XM (exponentially-weighted moving average) and delta checks may be informative. d) Follow your laboratory's standard operating procedure to confirm unexpected results. - Ongoing investigation indicates that the probable root cause is the sweep flow disruption that may occur following the "Clear RBC Apertures" procedure. This potential root cause is currently under further investigation. Customers should discontinue using this procedure. If you suspect that your instrument has a clogged aperture that will not clear, discontinue use of the analyzer, contact Customer Support Center and request service. - Communicate to the ordering physicians the need to avoid patient treatment based solely on any single test resu

Recalling firm

Firm: Beckman Coulter Inc.
Address: 250 S Kraemer Blvd, Brea, California 92821-6232

Distribution

Distribution pattern: 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, Lithuania, Mexico, Morocco, Myanmar, Netherlands Antilles, New Zealand, Portugal, Romania, Russia, Saudi Arabia, Serbia, Slovenia, Spain, Switzerland, Trinidad and Tobago, U.A.E, United Kingdom, and Vietnam.

Timeline

Recall initiated: 2018-07-30
Posted by FDA: 2019-05-23
Terminated: 2022-03-31
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #172923. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.