AlinityRecalls & reported problems across all models

We found 13 models of Alinity by Abbott Laboratories in the FDA's device registry (GUDID). Together they are named in 2,793 adverse event reports in the FDA's MAUDE database, received between Jan 19, 2018 and Sep 30, 2026 — classified as 1 death, 61 injuries, 2,731 malfunctions.

The most frequently reported specific device problem is “High Test Results” (900 reports).

10 FDA recall records name at least one of these models by its device identifier, 9 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Alinity recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Nov 13, 2025Open, Classified

   Abbott Laboratories is recalling their Alinity ci-series System Control Module, a chemistry/immunoassay anayzer, by correction. The reason for the recall is potential performance issues found in the Alinity ci-series System software versions 3.6.1. and lower that could lead to erroneous results for multiple analytes. The issue was identified by Abbott during the internal testing of complaint investigations.

   Z-0961-2026 · Root cause: Software design · Recall details · FDA record ↗

2. Sep 18, 2025Open, Classified

   Software issue for hq analyzer results in system not visibly applying appropriate flagging to results when saturation is present which may result in incorrect results.

   Z-0489-2026 · Root cause: Software design · Recall details · FDA record ↗

3. Jun 14, 2024Open, Classified

   1)If Complete Blood Count with differential and reticulocyte(CBC+Diff+Retic) sample is run, then immediately following on same rack CBC+Diff sample is run, then falsely low red blood cell count may occur, generating falsely high Mean Cell Hemoglobin(MCH)/MCHC and falsely low hematocrit results. 2)Cell events may be incorrectly counted as basophil(BASO), resulting in increased BASO and %BASO counts

   Z-2681-2024 · Root cause: Software design · Recall details · FDA record ↗

4. Oct 19, 2023Open, Classified

   The devices contain a dry natural rubber (latex) subcomponent, which are not labeled as containing dry natural rubber(latex).

   Z-0681-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

5. Oct 19, 2023Open, Classified

   The devices contain a dry natural rubber (latex) subcomponent, which are not labeled as containing dry natural rubber(latex).

   Z-0680-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

6. Sep 29, 2023Open, Classified

   A high recovery of Iron assay has been observed at some customer sites. Internal studies confirmed the positive shift of Quality Control and patient samples results, up to 15% for Iron Products (Alinity c Iron Reagent REF. 08P3920) to be used on Abbott Alinity Instrument and to 30% for Iron Products (IRON REF. 6K95-41 and IRON REF. 6K95- 30) to be used on Abbott Architect Instrument. When using the affected lots, there is a potential for delay in reporting patient results due to QC failure, also a potential for falsely elevated results.

   Z-0326-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

7. May 30, 2023Open, Classified

   There are potential performance issues found in the Alinity ci-series System software versions 3.4.0 and lower, including: 1) SCC Reagent load error during daily maintenance; 2) Sample Laboratory Report error; 3) Customer requests mechanism to prevent user error when creating new lots of value assigned Calibrators; 4) Error in processing tests after CCCintController encountered an error with the assay information downloaded from SCC; 5) The assay editor does not correctly check sample dilution total volume limits; 6) User-Applied Labels not adhering to Reagent Bottles; 7) ICT Module did not expire after warranty was exceeded. These performance issues could lead to erroneous results for multiple analytes.

   Z-0613-2024 · Root cause: Software design · Recall details · FDA record ↗

8. Nov 24, 2022Open, Classified

   Reaction vessels may contain a potential contaminant that could affect their optical performance.

   Z-0958-2023 · Root cause: Material/Component Contamination · Recall details · FDA record ↗

9. Feb 3, 2022Open, Classified

   Software error associated with the immunoassay analyzer wash cycle which is using 1 mL of wash buffer instead of the intended 3 mL of wash buffer to wash the exterior of the probe.

   Z-0749-2022 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

10. Jun 28, 2019Terminated

    Added an additional SmartWash parameter for the Lithium and Alinity c Lithium Reagent Kit, catalogue number 8L25-30 and 08P5320 to prevent the potential for carryover from the ARCHITECT Lactate Dehydrogenase (LDH) reagent (LN 2P56) may result infalsely elevated lithium patient results

    Z-2552-2019 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported Alinity problems

Alinity models

13 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Alinity 03R6701

  ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
  1 recall1 death1,197 reports
• Alinity 03R6501

  ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
  1 recall911 reports
• Alinity 03R7001

  ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
  2 recalls498 reports
• Alinity 09P6801

  Counter, differential cell
  2 recalls96 reports
• Alinity 06P1601

  Test, equipment, automated bloodborne pathogen
  1 recall84 reports
• Alinity 06P1401

  ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE
  1 recall0 reports
• Alinity 08P3920

  Photometric method, iron (non-heme)
  1 recall0 reports
• Alinity 08P5320

  Assay, porphyrin, spectrophotometry, lithium
  1 recall0 reports
• Alinity 09P6901

  Slide stainer, automated
  2 reports
• Alinity 06R9020

  Reagent, coronavirus serological
  2 reports
• Alinity 06P0161
  1 report
• Alinity 06P0861
  1 report
• Alinity 06P0761
  1 report

Recent Alinity adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2026False Positive Result

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50954177 ↗
• MalfunctionSep 30, 2026False Positive Result

  The customer observed false reactive Alinity i Anti-HBc results generated on the Alinity i PROCESSING MODULE. The following data was provided:(43-year-old female) SID (b)(6) initial Anti-HBc result 1.16 S/CO, repeated 1.16 / 1.04 / 0.10 / 0.11 / 0.13 S/CO.(48-year-old male) SID (b)(6) initial Anti-HBc result 1.51 S/CO, repeated 1.70 / 1.74 / 0.11 / 0.12 / 0.11 S/CO.(31-year-old female) SID (b)(6) initial Anti-HBc result 2.16 S/CO, repeated 2.27 / 2.40 / 0.25 / 0.18 / 0.14 S/CO.SID (b)(6) initial result 1.28 S/CO (reactive), repeated 1.44 and 1.35 S/CO,SID (b)(6) initial result 1.00 S/CO (reactive), repeated 1.22 and 1.15 S/CO,SID (b)(6) initial result 1.13 S/CO (reactive), repeated 1.30 and 1.41 S/CO,SID (b)(6) initial result 2.67 S/CO (reactive), repeated 2.78 and 0.11 S/CO.No impact to patient management was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50947484 ↗
• MalfunctionSep 29, 2026False Negative Result

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50938610 ↗
• MalfunctionSep 29, 2026High Test Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50932377 ↗
• MalfunctionSep 29, 2026High Test Results

  The customer reported a falsely elevated Alinity c Magnesium (Mg) result generated on the Alinity c Processing Module. The following data was provided:SID 7862520115:Initial Magnesium result = 8.9 mg/dLRepeat Magnesium result = 1.8 mg/dL (Reference range: 1.6-2.6 mg/dL)QC values for Magnesium were within range. There was no impact to patient management reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50931443 ↗
• MalfunctionSep 28, 2026High Test Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50922284 ↗
• MalfunctionSep 25, 2026Low Test Results

  The customer observed a falsely decreased Alinity c Carbon Dioxide result for one patient. The following data was provided (Customer¿s reference range is 19-29 mmol/L):Sample ID (b)(6) initial result, on (b)(6) 2026, was 18, repeat result on a different analyzer was 22 mmol/L. There was no impact to patient management reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50899273 ↗
• MalfunctionSep 24, 2026High Test Results

  The customer observed falsely elevated Alinity i Free T4 results for multiple patients. Results were released from the laboratory. Same sample was used for the repeat testing. The following results were provided: (Customer provided reference range: : 9.00 to 20.00 pmol/L).(b)(6) 2026, SID (b)(6); Initial result => 64.35 pmol/L, repeat results on (b)(6) 2026 (b)(6)= 19.72 pmol/L and 11SEP2026= 20.22 pmol/L.(b)(6) 2026, SID: (b)(6); Initial result = 22.55 pmol/L, repeat results on (b)(6) 2026 (b)(6)= 13.27 pmol/L.(b)(6) 2026, SID: (b)(6); Initial result = 24.48 pmol/L, repeat results on (b)(6) 2026 (b)(6)= 13.18 pmol/L.No additional patient information was available. No impact to patient management was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50881801 ↗
• MalfunctionSep 23, 2026High Test Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50872184 ↗
• MalfunctionSep 23, 2026Low Test Results

  The customer observed falsely depressed Alinity c Sodium results for one 66-year-old male patient on the Alinity serial number (b)(6). The sample was repeated with higher results. The following data was provided:SID: (b)(6) processed on (b)(6) 2026.Initial result processed on Alinity c serial number, (b)(6), Sodium = 118 Repeat processed on (b)(6) and (b)(6) = 141 and 142 mmol/L.Sodium Reference Range: 136-145 mmol/L No impact to patient management was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50871826 ↗
• MalfunctionSep 23, 2026High Test Results

  The customer reported falsely elevated Alinity I STAT High Sensitivity Troponin-I results for multiple patients. The following data was provided (customer provided diagnostic cutoff is >/= 28 ng/L):(b)(6) 2026, SID (b)(6) (49 year old female):initial result = 46.8 ng/L, repeat = 96.1 ng/mL, repeat on another analyzer = 6.3 ng/L.(b)(6) 2026, SID (b)(6) (41 year old female): Initial = 54.4 ng/L, repeat was < 2.7 ng/L, repeat on another analyzer was <2.7 ng/:A new sample was collected: SID (b)(6).Initial = 11.9 ng/L, repeat was <2.7 ng/L, repeat on another analyzer was <2.7 ng/L. The customer believes the results generated on the other analyzer are the correct results.No impact to patient management was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50869570 ↗
• MalfunctionSep 23, 2026Low Test Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50869449 ↗
• MalfunctionSep 22, 2026High Test Results

  The customer observed falsely elevated Magnesium results generated from Alinity c processing module for a 74yrs old male patient. The results provided were: On (b)(6) 2026: SID (b)(6): Initial=6.71 mg/dL /repeated=1.89 mg/dL. Repeated on Alinity (b)(6)=1.94 mg/dL. Customer reference range for Magnesium=2.09 to 2.84 mg/dL. There was no reported impact to patient management.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50856020 ↗
• MalfunctionSep 21, 2026Smoking

  The customer observed smoke from the RSH Load/Unload Board during a module restart. The Alinity i Processing Module, serial number (b)(6), was immediately shut down. As a corrective action, the PSCB RSM Load/Unload Controller board and the RSM 2 Axis Driver board were replaced. No impact to patient management and no impact to user safety was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50841613 ↗
• MalfunctionSep 18, 2026Low Test Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50820035 ↗

Other Abbott Laboratories products

• ARCHITECT51 models · 5,426 reports · 11 recalls
• CELL-DYN12 models · 918 reports · 6 recalls
• ABBOTT PRISM9 models · 145 reports