Sysmex pocH-100i Automated Hematology Analyzer Recalled for Data Omission
Sysmex America Inc is recalling 193 pocH-100i Automated Hematology Analyzers because the thermal printer may omit digits or decimal points in printed results.
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 potential data omission in printed results without reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Sysmex America Inc is recalling 193 units of the pocH-100i Automated Hematology Analyzer. The recall was initiated because the data printed on the device's thermal printer may omit a digit or decimal point in the test results or sample identification number. This defect could lead to inaccurate documentation of in vitro diagnostic results.
The affected devices are intended for use in CLIA non-waived clinical laboratories and are not for point-of-care use in CLIA waived laboratories. The recall covers units distributed nationwide in the United States, including Puerto Rico, as well as in Canada. Specific serial numbers are listed in the agency's recall record.
Clinical laboratories should contact Sysmex America Inc for instructions on how to address the issue. Users should verify printed data against the device's internal records to ensure accuracy.
The recalled product
- Product
- pocH-100i; sysmex; Automated Hematology Analyzer; 7.3" x 13.8" x 18.1" / 30.8 lbs.; Sysmex Corporation; 1-5-1 Wakinohama-Kaigandori, Chuo-ku, Kobe 651-0073, Japan; Sysmex America, Inc; One Nelson C. White Pkwy, Mundeline, IL 60060, U.S.A. The Sysmex pocH-100i Automated Hematol
- Manufacturer
- Sysmex America Inc
- Affected units
- 193
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 (20)
- Product Code: 023-1861-8
- Serial Numbers: B1677 - B1826
- F1827 - F2161
- F2178 - F2198
- F2216 - F2396
- F2411 - F2452
- F2464 - F2472
- F2495 - F2523
- F2533
- F2550 - F2560
- F2592 - F2601
- F2614 - F2635
- F2640 - F2648
- F2662 - F2679
- F2710 - F2853
- F2855 - F2871
- F2878 - F2922
- F2945
- F2946
- F2962 - F2970
Distribution
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