Reported Sep 24, 2025 · Ongoing
UniCel DxH 900 COULTER Cellular Analysis System, configured with the Led HGB Photometer REF: C11478
Beckman Coulter Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Beckman Coulter Inc. · 250 S Kraemer Blvd · Brea, CA · 92821-6232
Is this the product you have?
- UniCel DxH 900 COULTER Cellular Analysis System, configured
- with the Led HGB Photometer REFC11478
- Lot codes and dates
- UDI15099590701574/
- Serial Numbers
79 of 79 codes
BB33238BB33239BB42317BC05150BC08198BC10226BC16320BC21392BC23453BC25457BC25465BC30527BC32542BC42721BC42726BC49882BD13219BD41570BD46639BD46643BD46646BE01022BE02044BE02052BE04080BE21222BE24254BE24257BE29334BE31336BE33366BE42455BE42459BE46517BE49539BE49541BF10071BF12126BF12129BF18194BF33377BF40462BG04041BG04042BG04053BG05080BG11182BG11184BG11185BG14195BG14200BG14204BG14208BG16220BG16231BG17238BG17250BG17260BG19283BG20292
- Amount recalled
- N/A
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
Why it was recalled
Hematology analyzers configured with HGB photometers may result in erroneously high hemoglobin (HGB) results on samples with elevated white blood cell (WBC) counts.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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