Sysmex XN-Series Hematology Analyzers Recalled for Potential Elevated Values
Sysmex Corporation is recalling XN-10 and XN-20 hematology analyzers due to a potential for elevated hemoglobin and impedance platelet count values.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a potential for inaccurate diagnostic values (elevated hemoglobin and platelet counts), which poses a risk of harm to patients through misdiagnosis or inappropriate treatment, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Sysmex Corporation is recalling the XN-Series modules (XN-10 and XN-20), which are quantitative multi-parameter automated hematology analyzers intended for in vitro diagnostic use in clinical laboratories. The recall is issued because there is a potential for elevated hemoglobin (Hgb) and impedance platelet count (PLT-I) values.
The recall affects 1,137 units in the United States, 54 units in Canada, and 9 units in inventory. The correction is limited to XN-10 and XN-20 units distributed by Sysmex America, Inc., installed at end-user sites in the US, Puerto Rico, and Canada. Specific serial number ranges for the XN-10 and XN-20 models are identified in the official recall notice.
Clinical laboratories using these devices should contact Sysmex Corporation for instructions on how to address the potential for elevated values. The source text does not specify a deadline or additional consumer actions beyond the manufacturer's correction process.
The recalled product
- Product
- The XN-Series modules (XN-10, XN-20) are quantitative multi-parameter automated hematology analyzers intended for in vitro diagnostic use in screening patient populations found in clinical laboratories.
- Manufacturer
- Sysmex Corporation
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 (16)
- 1) Model: XN-10
- Catalog Number: AP795756
- Serial Numbers: 111001-15483 except 15287
- 15298
- 15308
- 15408
- 15442
- 15454
- 15470 and 15484
- 2) Model: XN-20
- Catalog Number: AE797961
- Serial Numbers: 11001-12118 except 11960
- 12039
- 12078
- 12114
- and 12117.
Distribution
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