Sysmex XE-2100C Hematology System Recalled for Reticulocyte Count Bias
Sysmex America is recalling 69 XE-2100C automated hematology systems because reticulocyte counts may be 21% lower than expected.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 bias in diagnostic results without reported injuries or illnesses, fitting the criteria for a moderate severity recall.
Plain-English summary
Sysmex America, Inc. is recalling 69 units of the Sysmex XE-2100C Automated Hematology System. This device is an automated differential cell counter used for in vitro diagnostic screening in clinical laboratories. The recall covers catalog number 053-2311-4 and all serial numbers.
The recall was initiated because there is a variation in reticulocyte counts between the XE Series and XT-Series hematology analyzers. Specifically, the XE-Series devices may produce reticulocyte counts that are an average of 21% lower due to a low bias. This discrepancy may affect the accuracy of diagnostic results for patient populations screened in clinical laboratories.
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-2100C Automated Hematology System; an automated differential cell counter; Sysmex Corporation, Kobe, Japan; Sysmex America, One Nelson C. White Parkway, Mundelein, IL 60060; catalog #053-2311-4 The Sysmex XE-2100C is an automated hematology analyzer for in vitro…
- Manufacturer
- Sysmex America, Inc.
- Hazard
- Affected units
- 69
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 ##053-2311-4
- 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.
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