Sysmex XE-5000 Hematology System Recalled for Reticulocyte Count Bias
Sysmex America is recalling 763 XE-5000 automated hematology systems because reticulocyte counts may be 21% lower than expected due to a low bias.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a systematic measurement bias in diagnostic results without reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Sysmex America, Inc. is recalling 763 units of the Sysmex XE-5000 Automated Hematology System. This device is an automated differential cell counter used in clinical laboratories for in vitro diagnostic screening of patient populations. The recall covers catalog number 063-7591-7 and all serial numbers.
The recall is due to a variation in reticulocyte counts between the XE Series (XE-2100, XE-5000) and XT-Series (XT-2000i, XT-4000i) hematology analyzers. This variation may result in reticulocyte counts that are an average of 21% lower on the XE-Series because of a low bias.
The affected units were distributed nationwide in the United States, including Puerto Rico. Clinical laboratories using these devices should contact Sysmex America for further instructions regarding the recall and potential corrective actions.
The recalled product
- Product
- Sysmex XE-5000 Automated Hematology System; an automated differential cell counter; Sysmex Corporation, Kobe, Japan; Sysmex America, One Nelson C. White Parkway, Mundelein, IL 60060; catalog #063-7591-7 The Sysmex XE-5000 is an automated hematology analyzer for in vitro diagn
- Manufacturer
- Sysmex America, Inc.
- Affected units
- 763
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- catalog #063-7591-7
- all serial numbers
Distribution
Part of a larger recall action
This product is one of 3 recalled by Sysmex America, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
Same manufacturer · Sysmex America, Inc.
See all →- ModerateLaboratory tube sorters recalled over a lift that may drop unexpectedly
FDA (Devices) · 2026-01-28
- HighSysmex PS-10 Sample Preparation System Recalled for False Test Results
FDA (Devices) · 2025-02-12
- HighSysmex PS-10 Sample Preparation System Recalled for Insufficient Antibody
FDA (Devices) · 2020-07-29
- HighSysmex CF-70 Blood Smear Transporter Recalled for Software Mismatch Hazard
FDA (Devices) · 2020-04-22
- SevereSysmex CV-11 Sample Unit Recalled for Combustion Hazard
FDA (Devices) · 2020-04-22
Same hazard · measurement bias
See all →- HighEmano Flow Uroflowmetry App Recalled Over Biased Flow Estimates
FDA (Devices) · 2026-07-29
- HighStago D-dimer assay shows positive bias across entire analytical range
FDA (Devices) · 2026-03-25
- HighCapillary tubes recalled over a positive bias in potassium results
FDA (Devices) · 2026-02-25
- HighVITROS Chemistry CRP Diagnostic Slides May Underreport Elevated Results
FDA (Devices) · 2024-12-04
- Highepoc BGEM BUN Test Cards recalled for sodium measurement bias
FDA (Devices) · 2024-11-13