AlinityRecalls & reported problems across all models

We found 22 models of Alinity by Abbott Ireland in the FDA's device registry (GUDID). Together they are named in 643 adverse event reports in the FDA's MAUDE database, received between Aug 20, 2018 and Sep 29, 2026 — classified as 4 injuries, 639 malfunctions.

The most frequently reported specific device problem is “High Test Results” (424 reports).

7 FDA recall records name at least one of these models by its device identifier.

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 21, 2018Terminated

   Abbott has become aware of a manufacturing issue that can result in damage to a bottle neck in some of the reagent cartridges found in the lots listed in Appendix A. If a bottle neck is damaged, it may cause a failure during the reagent loading process on the Alinity i instrument.

   Z-2208-2019 · Root cause: Device Design · Recall details · FDA record ↗

2. Nov 21, 2018Terminated

   Abbott has become aware of a manufacturing issue that can result in damage to a bottle neck in some of the reagent cartridges found in the lots listed in Appendix A. If a bottle neck is damaged, it may cause a failure during the reagent loading process on the Alinity i instrument.

   Z-0669-2019 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

3. Nov 21, 2018Terminated

   Abbott has become aware of a manufacturing issue that can result in damage to a bottle neck in some of the reagent cartridges found in the lots listed in Appendix A. If a bottle neck is damaged, it may cause a failure during the reagent loading process on the Alinity i instrument.

   Z-0668-2019 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

4. Nov 21, 2018Terminated

   Abbott has become aware of a manufacturing issue that can result in damage to a bottle neck in some of the reagent cartridges found in the lots listed in Appendix A. If a bottle neck is damaged, it may cause a failure during the reagent loading process on the Alinity i instrument.

   Z-0667-2019 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

5. Nov 21, 2018Terminated

   Abbott has become aware of a manufacturing issue that can result in damage to a bottle neck in some of the reagent cartridges found in the lots listed in Appendix A. If a bottle neck is damaged, it may cause a failure during the reagent loading process on the Alinity i instrument.

   Z-0666-2019 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

6. Nov 21, 2018Terminated

   Abbott has become aware of a manufacturing issue that can result in damage to a bottle neck in some of the reagent cartridges found in the lots listed in Appendix A. If a bottle neck is damaged, it may cause a failure during the reagent loading process on the Alinity i instrument.

   Z-0665-2019 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

7. Nov 21, 2018Terminated

   Abbott has become aware of a manufacturing issue that can result in damage to a bottle neck in some of the reagent cartridges found in the lots listed in Appendix A. If a bottle neck is damaged, it may cause a failure during the reagent loading process on the Alinity i instrument.

   Z-0664-2019 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Most reported Alinity problems

Alinity models

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

• Alinity 07P7030

  RADIOIMMUNOASSAY, FREE THYROXINE
  1 recall168 reports
• Alinity 07P4830

  RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE
  2 recalls91 reports
• Alinity 07P7020

  RADIOIMMUNOASSAY, FREE THYROXINE
  79 reports
• Alinity 04Z2125

  IMMUNOASSAY METHOD, TROPONIN SUBUNIT
  74 reports
• Alinity 07P5121

  SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN
  1 recall15 reports
• Alinity 07P6530

  FERRITIN, ANTIGEN, ANTISERUM, CONTROL
  1 recall7 reports
• Alinity 08P4532

  SYSTEM, TEST, VITAMIN D
  1 recall3 reports
• Alinity 08P3620

  RADIOIMMUNOASSAY, PROGESTERONE
  1 recall1 report
• Alinity 07P4820

  RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE
  44 reports
• Alinity 07P6620

  RADIOIMMUNOASSAY, PROLACTIN (LACTOGEN)
  31 reports
• Alinity 08P1934

  PHOTOMETRIC METHOD, MAGNESIUM
  30 reports
• Alinity 04Z2135

  IMMUNOASSAY METHOD, TROPONIN SUBUNIT
  26 reports
• Alinity 08P1925

  PHOTOMETRIC METHOD, MAGNESIUM
  20 reports
• Alinity 04T9120

  ALKALINE PICRATE, COLORIMETRY, CREATININE
  15 reports
• Alinity 07P5020

  RADIOIMMUNOASSAY, ESTRADIOL
  12 reports
• Alinity 07P6630

  RADIOIMMUNOASSAY, PROLACTIN (LACTOGEN)
  10 reports
• Alinity 07P5030

  RADIOIMMUNOASSAY, ESTRADIOL
  6 reports
• Alinity 07P5131

  SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN
  5 reports
• Alinity 04U0520

  BILIRUBIN (TOTAL AND UNBOUND) IN THE NEONATE TEST SYSTEM
  3 reports
• Alinity 04T9820

  Photometric method, iron (non-heme)
  1 report
• Alinity 09P6324

  IGM, ANTIGEN, ANTISERUM, CONTROL
  1 report
• Alinity 08P0424

  TURBIDIMETRIC METHOD, PROTEIN OR ALBUMIN (URINARY, NON-QUANT.)
  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 29, 2026High Test Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50932189 ↗
• MalfunctionSep 28, 2026High Test Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50923280 ↗
• MalfunctionSep 28, 2026High Test Results

  The customer reported falsely elevated Alinity I Free T4 generated from Alinity i Processing Module (SN:(b)(6)) and provided the following data for a 74 year old female patient:On (b)(6)2026, Sample ID (b)(6) initial result was 24.4 pmol/L and when repeated on another Alinity i Processing Module, the result was 13.7 pmol/ L (Customer Normal range: 9-19.9 pmol/L).Other laboratory data provided:TSH was 2.29 mIU/L (Reference range: 0.35-4.94)Per the customer discrepant results were not reported out to the medical provider. There was no reported impact to patient management.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50916380 ↗
• MalfunctionSep 21, 2026High Test Results

  The customer reported falsely elevated Alinity i Free T4 results for multiple patients. The following data were provided:SID (b)(6)(female, born 1947)(7SEP2026)Initial: >64.35 pmol/L,Repeat: 19.13 pmol/L, 17.70 pmol/L.SID (b)(6)(male, born 1979)((b)(6) 2026)Initial: >64.35 pmol/L.Repeat: 15.31 pmol/L. No impact to patient management was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50846171 ↗
• MalfunctionSep 21, 2026Low Test Results

  The customer reported falsely depressed Alinity i TSH results for three patients. The samples were repeated with higher results. The following data was provided:Initial Results:Sample id: (b)(6) : < 0.0083 mIU/mL,Sample id: (b)(6) : <0.0131 mIU/mL,Sample id: (b)(6) : < 0.0083 mIU/mL.Rerun results:Sample id:(b)(6): 1.3704 mIU/mL,Sample id:(b)(6) : 3.7146 mIU/mL,Sample id:(b)(6) : 0.8114 mIU/mL There was no impact to patient management reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50842562 ↗
• MalfunctionSep 16, 2026High Test Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50794333 ↗
• MalfunctionSep 16, 2026High Test Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50794332 ↗
• MalfunctionSep 16, 2026High Test Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50794211 ↗
• MalfunctionSep 16, 2026High Test Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50794208 ↗
• MalfunctionSep 16, 2026High Test Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50791568 ↗
• MalfunctionSep 15, 2026High Test Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50780513 ↗
• MalfunctionSep 15, 2026High Test Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50778619 ↗
• MalfunctionSep 15, 2026High Test Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50778053 ↗
• MalfunctionSep 15, 2026High Test Results

  The customer observed elevated Alinity i STAT High Sensitivity Troponin-I results for a 75-year-old patient diagnosed with lung cancer status post left lobectomy in (b)(6) 2026. The patient presented with increased shortness of breath with activities of daily living (ADLs) and sharp pain to left upper quadrant. The patient had an EKG, chest x-ray and pulmonary CT (contrast) completed prior to transferring to the hospital. The following data was provided: (b)(6) 2026, SID: (b)(6). Alinity i STAT High Sensitivity Troponin-I results: 512.2 pg/mL, 548.8 pg/mL, 492.3 pg/mL, 506.8 pg/mL, 506.5 pg/mL,528.3 pg/mL, 521.1 pg/mL. Repeat testing on all instruments remained consistent with the initial findings. The specimen was also tested on the Beckman Access 2 and the result was 11 ng/L (Beckman reference range 16-49 ng/L is Abnormal High). The patient was transferred to ESJ and the Beckman Troponin results at ESJ were 14 ng/L and 15 ng/L. Other results provided: BNP result 607 and 632 pg/mL. There was no negative impact to patient management reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50771676 ↗
• MalfunctionSep 15, 2026High Test Results

  The customer reported a falsely elevated Alinity c Creatinine2 result generated on the Alinity c Processing Module. The questioned creatinine result did not match previous results, and the patient was admitted to the hospital. The following data was provided:(b)(6)2026, SID (b)(6): Initial Creatinine2 result = 2.37 mg/dL (Normal range: 0.72 to 1.25 mg/dL)(b)(6)2026, Repeat Creatinine2 result = 0.70 mg/dL (measured from original sample stored in the refrigerator) There was no impact to patient management reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50771439 ↗

Other Abbott Ireland products

• ARCHITECT38 models · 1,140 reports · 4 recalls