RegWardenFDA facility compliance records
Facility

DATA INNOVATIONS, LLC

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

Activity by year

FDA actions on record by year2013: 1 recalls; 2014: 2 recalls; 2016: 1 inspections; 2018: 1 recalls1’132’14’151’16’171’18’19’20’21’22’23’24’25’26
  • Recalls (4)
  • Inspections (1)

Devices registered here (1)

  • Blood Establishment Computer Software And Accessories
    Product code MMH (opens in a new tab) · Class II · Hematology · 21 CFR 864.9165

Recalls & enforcement

  • Class IITerminated2018-08-29
    Quality control results are not processed for Abbott Diagnostics Alinity ci series (abdicqii) instrument. This has been determined to be a driver malfunction. When an instrument transmits results from a quality control (QC) sample ID ("Q^Control" in SPM segment), and the option…
  • Class IITerminated2014-10-23
    Software issue resulting in the results of one patient potentially being associated with another.
  • Class IITerminated2014-08-15
    Potential issues with the ProVue driver have been identified which may cause data to be misassociated with patient results under a given set of circumstances.
  • Class IITerminated2013-11-06
    When connected to the Sysmex UF-100, the Instrument Manager driver sysu100i driver software versions 7.00.0001, 7.00.0002, 7.00.0003, 7.00.0004, 7.00.0005, 8.00.0001, 8.00.0002, 8.00.0003, and 8.00.0004, and is configured with option "Strip Zeros from Result" set to "Yes" may …

FDA inspections (1)

  • VAI2016-09-01
    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. “DATA INNOVATIONS, LLC (FEI 3001451449) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3001451449-data-innovations-llc/

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