RegWardenFDA facility compliance records
Facility

SYSMEX REAGENTS AMERICA, INC.

13 recall(s) on record — most severe on record: Class II.

Activity by year

FDA actions on record by year2012: 1 recalls; 2013: 2 recalls; 2014: 1 recalls; 2016: 1 recalls, 1 inspections; 2017: 2 recalls; 2018: 1 recalls; 2020: 3 recalls; 2025: 2 recalls1’122’131’14’152’162’171’18’193’20’21’22’23’242’25’26
  • Recalls (13)
  • Inspections (1)

Devices registered here (1)

Recalls & enforcement

20252 records
  • Class IIOngoing2025-12-15
    Under specific conditions, the lift's electromagnetic holding force may disengage unexpectedly, allowing unintended downward movement of the lift.
  • Class IIOngoing2025-01-06
    Sysmex was made aware of a report of false results due to carry-over caused by the sporadic omission of the probe wash step during antibody pipetting on the PS-10 Sample Preparation System.
20203 records
  • Class IITerminated2020-07-06
    Insufficient amount of antibody without an error message or alarm
  • Class IITerminated2020-03-09
    Software mismatch-When the software versions between the SP-50 and CF-70 are not matched, and an error condition occurs requiring the operator to open the cover door of the CF-70 to remove slides or slide magazines from the CF-70, the operation of the CF-70 does not halt.
  • Class IITerminated2020-01-21
    When excessive amounts of urine spills on the rack transport track and reaches the electrical components of the CV-11 conveyor, there is a potential for smoke and/or sparks which may present a combustion hazard.
20181 record
  • Class IITerminated2018-07-27
    The fluorescent platelet counts (PLT-F) and immature platelet fraction (IPF) values can be falsely low when using affected lots of Fluorocell PLT.
20172 records
  • Class IICompleted2017-09-08
    There is potential that fluorescent platelet (PLT-F) and immature platelet fraction (IPF%, #) results obtained using the lots listed above may exhibit lower than actual PLT-F and IPF values. The issue may be recognized by a large discrepancy between the impedance platelet (PLT-I…
  • Class IITerminated2017-03-23
    Reported customer complaints of automated hematology analyzers catching fire due to misalignment of an internal protective sheet that shields electronic components from salty reagents. Build-up of salt deposits on unprotected electronic components may combust due to heat genera…
20161 record
  • Class IITerminated2016-07-01
    There is a potential that fluorescent platelet (PLT-F) and immature platelet fraction (IPF%) results performed using the recalled lots may exhibit lower than expected PLT-F and IPF values. The issue may be recognized by a large discrepancy between the Impedance platelet (PLT-I) v…
20141 record
20132 records
  • Class IITerminated2013-05-15
    The data printed on the thermal printer may omit a digit or decimal point in the results or sample identification number.
  • Class IITerminated2013-03-31
    The current Century Break patch did not contain the same setting for the Century Break year for both the Red Hat Linux and GUI files. Due to the mismatch in file settings, the software could not properly calculate a purge date for the database files based on the customer data ret…
20121 record
  • Class IITerminated2012-06-01
    There is a variation of reticulocyte counts between XE Series (XE-2100, XE-5000) and XT-Series (XT-2000i, XT-4000i) hematology analyzers that may result in a retic counts that are an average of 21% lower on the XE-Series because of a low bias.

FDA inspections (1)

  • VAI2016-06-07
    Voluntary Action Indicated · Compliance: Devices · citations posted

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

Related

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “SYSMEX REAGENTS AMERICA, INC. (FEI 3006949423) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3006949423-sysmex-reagents-america-inc/

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