RegWardenFDA facility compliance records
Company

Diagnostica Stago, Inc.

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

Recalls by year

FDA actions on record by year2012: 1 recalls; 2013: 1 recalls; 2014: 1 recalls; 2017: 1 recalls; 2018: 2 recalls; 2019: 1 recalls; 2020: 1 recalls; 2023: 1 recalls; 2025: 4 recalls; 2026: 3 recalls1’121’131’14’15’161’172’181’191’20’21’221’23’244’253’26
  • Recalls (16)

Registered facilities (1)

Recalls & enforcement

20263 records
  • Class IIOngoing2026-07-29
    A positive drift in QC values within the reagent's stated 4-hour onboard stability period was identified
  • Class IIOngoing2026-02-05
    After receiving customer complaints, investigations confirmed the presence of a positive bias in D-Dimer measurements throughout the entire analytical range.
  • Class IIOngoing2026-02-04
    The potential of out-of-range results and an underestimation of the free protein S level in normal patient plasmas. The defect only affects normal-range values.
20254 records
  • Class IIOngoing2025-12-15
    Potential for defect for Asserachrom HPIA lot 271288, which can affect every well in the impacted strip and produce negative results.
  • Class IIOngoing2025-09-12
    A potential risk of underestimation of D-Dimer (D-Di) levels with the two listed lots.
  • Class IIOngoing2025-07-21
    Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH applications.
  • Class IIOngoing2025-05-21
    Potential for shorter clotting times in clotting tests which have a dilution, leading to possible overestimate of around 1%
20231 record
  • Class IIOngoing2023-03-22
    An internal investigation identified a bug in this firmware version, resulting in the following:Intermittent shortened coagulation times and an increased frequency of occurrence of a technical error reported by the analyzer (error 13).
20201 record
  • Class IITerminated2020-03-04
    A risk of sample-to-sample cross-contamination of Emicizumab for factor VIII assays on Stago instruments, clotting times will be shortened that may cause factor VIII levels reported to be falsely increased
20191 record
  • Class IITerminated2019-11-18
    A positive bias was confirmed to exists on the STA - Unicalibrator levels with STA - Deficient IX and STA - Deficient VIII when compared to the International Standard (IS) for factor VIII or IX. This bias is also observed on several External Quality Assessment (EQA) results.
20182 records
  • Class IITerminated2018-11-14
    There have been reports of shortened (T1-T2) results, where some instances of result recovery outside of the range of less than or equal to 15 seconds.
  • Class IITerminated2018-07-24
    QC values outside of the assigned ranges (prolonged Prothrombin time / decreased PT %)
20171 record
20141 record
  • Class IIITerminated2014-07-18
    Diagnostica Stago Inc. received some customer complaints regarding a misreading of Reagent 1 (substrate) barcode on STA analyzers.
20131 record
  • Class IITerminated2013-01-28
    Diagnostica Stago has confirmed that sometimes the delta OD measured can be changed leading to a lowered percentage result.
20121 record
  • Class IITerminated2012-06-15
    Following a single customer complaint that incorrect INR values were occasionally printed for PT tests, even though the primary units (seconds) were correct, the firm investigated and confirmed the potential for printing incorrect secondary units when using an external printer an…

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.

Cite this record

RegWarden. “Diagnostica Stago, Inc. — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-9003476-diagnostica-stago-inc/

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