AlinityRecalls & reported problems across all models

We found 37 models of Alinity by Abbott GmbH in the FDA's device registry (GUDID). Together they are named in 521 adverse event reports in the FDA's MAUDE database, received between Dec 26, 2017 and Sep 14, 2026 — classified as 28 injuries, 493 malfunctions.

The most frequently reported specific device problem is “High Test Results” (224 reports).

3 FDA recall records name at least one of these models by its device identifier, 3 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. Apr 24, 2025Open, Classified

   transit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled storage conditions. This failure could increase the probability of an incorrect test result or a delayed test result.

   Z-1853-2025 · Root cause: Storage · Recall details · FDA record ↗

2. Mar 4, 2024Open, Classified

   Customer complaints were received regarding falsely elevated results for some patient samples. Internal studies with customer return samples confirmed potential interactions that may lead to falsely elevated results when processed as below on the same instrument: " ARCHITECT Syphilis TP (LN 8D06) and/or ARCHITECT AdviseDx SARS-CoV-2-IgG II (LN 6S60) precedes ARCHITECT Anti-HCV testing (LN 1L79). " Alinity i Syphilis TP (LN 07P60) precedes Alinity i Anti-HCV testing (LN 08P05).

   Z-1480-2024 · Root cause: Device Design · Recall details · FDA record ↗

3. Jun 9, 2022Open, Classified

   There is a potential for falsely elevated Hemoglobin %A1c and Hemoglobin A1c results to be generated using the ARCHITECT and Alinity c Hemoglobin A1c assay.

   Z-1455-2022 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported Alinity problems

Alinity models

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

• Alinity 07P7220

  ENZYMATIC, CARBON-DIOXIDE
  90 reports
• Alinity 08P4320

  Hemoglobin A1c test system
  1 recall7 reports
• Alinity 07P5720

  AZO DYE, CALCIUM
  55 reports
• Alinity 06P0160
  53 reports
• Alinity 08P0521

  Assay, enzyme linked immunosorbent, hepatitis c virus
  1 recall2 reports
• Alinity 07P5730

  AZO DYE, CALCIUM
  51 reports
• Alinity 09P2720

  ANTIBODIES, ANTI-CYCLIC CITRULLINATED PEPTIDE (CCP)
  1 recall0 reports
• Alinity 06P0760
  36 reports
• Alinity 04V5121

  BILIRUBIN (TOTAL AND UNBOUND) IN THE NEONATE TEST SYSTEM
  36 reports
• Alinity 06P0460
  34 reports
• Alinity 07P9920

  ALKALINE PICRATE, COLORIMETRY, CREATININE
  24 reports
• Alinity 06P0850
  23 reports
• Alinity 06P0660
  18 reports
• Alinity 07P9930

  ALKALINE PICRATE, COLORIMETRY, CREATININE
  15 reports
• Alinity 04V5131

  BILIRUBIN (TOTAL AND UNBOUND) IN THE NEONATE TEST SYSTEM
  13 reports
• Alinity 04T7520

  RADIOIMMUNOASSAY, IMMUNOREACTIVE INSULIN
  11 reports
• Alinity 08P1920

  PHOTOMETRIC METHOD, MAGNESIUM
  9 reports
• Alinity 07P7420

  NAD REDUCTION/NADH OXIDATION, LACTATE DEHYDROGENASE
  6 reports
• Alinity 07P7230

  ENZYMATIC, CARBON-DIOXIDE
  5 reports
• Alinity 04W5660
  5 reports
• Alinity 08P3221

  SYSTEM, TEST, CARBOHYDRATE ANTIGEN (CA19-9), FOR MONITORING AND MANAGEMENT OF PANCREATIC CANCER
  4 reports
• Alinity 07P5520

  HEXOKINASE, GLUCOSE
  3 reports
• Alinity 07P5530

  HEXOKINASE, GLUCOSE
  3 reports
• Alinity 08P0721

  Test, HIV detection
  2 reports
• Alinity 08P4920

  TEST, EPITHELIAL OVARIAN TUMOR-ASSOCIATED ANTIGEN (CA125)
  2 reports
• Alinity 08P4930

  TEST, EPITHELIAL OVARIAN TUMOR-ASSOCIATED ANTIGEN (CA125)
  2 reports
• Alinity 08P4220

  NAD REDUCTION/NADH OXIDATION, CPK OR ISOENZYMES
  2 reports
• Alinity 08P1930

  PHOTOMETRIC METHOD, MAGNESIUM
  1 report
• Alinity 07P7430

  NAD REDUCTION/NADH OXIDATION, LACTATE DEHYDROGENASE
  1 report
• Alinity 08P4020

  Phosphomolybdate (colorimetric), inorganic phosphorus
  1 report
• Alinity 08P4030

  Phosphomolybdate (colorimetric), inorganic phosphorus
  1 report
• Alinity 08P2030

  NITROPHENYLPHOSPHATE, ALKALINE PHOSPHATASE OR ISOENZYMES
  1 report
• Alinity 08P0420

  TURBIDIMETRIC METHOD, PROTEIN OR ALBUMIN (URINARY, NON-QUANT.)
  1 report
• Alinity 08P3121

  RADIOIMMUNOASSAY, PARATHYROID HORMONE
  1 report
• Alinity 07P8421

  Test, hepatitis b (b core, be antigen, be antibody, b core igm)
  1 report
• Alinity 08P0702

  Test, HIV detection
  1 report
• Alinity 09P2635

  Radioassay, vitamin b12
  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 14, 2026Imprecise or Erratic Results

  The customer reported imprecise Alinity c Carbon Dioxide (CO2) results generated across multiple Alinity c Processing Modules. The customer stated that the anion gaps were running low. The following data was provided (Reference range: 22-29 mmol/L):(b)(6) (b)(6): units: mmol/LSID (b)(6): CO2 Initial = 30; Repeat = 28SID (b)(6): CO2 Initial = 30; Repeat = 27SID (b)(6): CO2 Initial = 30; Repeat = 28SID (b)(6): CO2 Initial = 31; Repeat = 29SID (b)(6): CO2 Initial = 22; Repeat = 20.Thelma (b)(6): units: mmol/LSID (b)(6): CO2 Initial = 30; Repeat = 28SID (b)(6): CO2 Initial = 30; Repeat = 28SID (b)(6): CO2 Initial = 31; Repeat = 28SID (b)(6): CO2 Initial = 22; Repeat = 21. There was no impact to patient management reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50754752 ↗
• MalfunctionSep 1, 2026High Test Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50549791 ↗
• MalfunctionAug 10, 2026False Negative Result

  The customer observed false nonreactive Alinity i Anti-HCV results on a patient. The results provided were:Initial=0.33 S/CO (< 1.00 S/CO=nonreactive) /repeated =0.33 and 0.34 S/COPrevious history in APRIL on Cobas Platform=6.88.There was no reported impact to patient management.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50195581 ↗
• MalfunctionMay 11, 2026High Test Results

  THE CUSTOMER OBSERVED A FALSELY ELEVATED ALINITY I ACTIVE B12 RESULT GENERATED ON AN ALINITY I PROCESSING MODULE FOR ONE PATIENT SAMPLE. SID (B)(6) RESULT ON LOT 12569UP00 = 29.7 PMOL/L, RESULT ON OTHER LOT = 18.1 PMOL/L. THERE WAS NO IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25136873 ↗
• MalfunctionApr 17, 2026Low Test Results

  THE CUSTOMER REPORTED FALSELY DECREASED CALCIUM GENERATED FROM ALINITY C PROCESSING MODULE AND PROVIDED THE FOLLOWING DATA: ON (B)(6) 2026, SAMPLE ID (B)(6) INITIAL RESULT WAS 5.8 AND REPEAT RESULT WAS 9.1 (CUSTOMER REFERENCE RANGE IS 8.7 - 10.7 MG/ DL) PATIENT INFORMATION: 85-YEAR-OLD MALE. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24916655 ↗
• MalfunctionApr 2, 2026False Negative Result

  THE CUSTOMER OBSERVED FALSE NEGATIVE ALINITY I ANTI-HBC RESULTS. ON (B)(6) 2026, SID (B)(6) (MALE, 69 YEARS OLD) WAS 0.95 S/CO GRAYZONE, REPEATED 0.30 S/CO NONREACTIVE, 0.23 S/CO NONREACTIVE, 0.23 S/CO NONREACTIVE. THE SAME SAMPLE WAS REPEATED ON SERIAL (B)(6) WITH THE SAME REAGENT LOT 76110BE00. ON (B)(6) 2026 RESULT WAS 1.65 S/CO REACTIVE, 1.44 S/CO REACTIVE, 1.51 S/CO REACTIVE. IT IS UNKNOWN WHAT RESULT WAS REPORTED OUT OF LAB. REFERENCE LAB RESULT CAME BACK AS NONREACTIVE. ADDITIONALLY, THE CUSTOMER PULLED SAMPLES THAT ALREADY RESULTED FROM THIS INSTRUMENT AND RAN THEM ON SERIAL (B)(6), WITH DIFFERENT RESULTS FROM 2 SAMPLES. ON (B)(6) 2026, SID (B)(6) WAS 2.58 S/CO REACTIVE, REPEAT 0.69 NONREACTIVE, 2ND REPEAT 4.87 REACTIVE. SID (B)(6) WAS REPORTED AS REACTIVE, BUT ON (B)(6) 2026 REPEATED ON SERIAL (B)(6) RESULT OF 0.22 S/CO NONREACTIVE. ON (B)(6) 2026, SID (B)(6) WAS 1.43, 1.99 S/CO REACTIVE. SID (B)(6) WAS REPORTED AS REACTIVE BUT ON (B)(6) 2026 REPEATED ON SERIAL (B)(6) RESULT OF 0.74 S/CO NONREACTIVE. NORMAL REFERENCE RANGE OF <0.80 S/CO NONREACTIVE, GRAYZONE OF 0.80 TO <1.21 S/CO, REACTIVE OF = 1.21 S/CO. NO ADDITIONAL PATIENT INFORMATION WAS PROVIDED. NO IMPACT TO PATIENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24772037 ↗
• MalfunctionMar 31, 2026Low Test Results

  THE CUSTOMER REPORTED A FALSELY DECREASED ALINITY I CA 125 II RESULT FOR A 75 YEAR OLD FEMALE PATIENT, WHICH WAS INCONSISTENT WITH THE PATIENT¿S HISTORICAL RESULTS. IT IS UNKNOWN WHETHER THE PATIENT HAS EPITHELIAL OVARIAN CANCER. THE PATIENT QUESTIONED THE RESULT, AND THE SAMPLE WAS REPEATED, YIELDING HIGHER RESULTS. THE FOLLOWING DATA WERE PROVIDED: SID (B)(6): (B)(6) 2026 INITIAL RESULT = 16.8 U/ML (NEGATIVE). REPEAT RESULT = >1000 U/ML. REPEAT RESULT (1:10 DILUTION) = >10,000 U/ML. HISTORICAL RESULTS: (B)(6) 2025 RESULT = 8998.0 U/ML (POSITIVE). (B)(6) 2025 RESULT = 4001.0 U/ML (POSITIVE). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24746116 ↗
• MalfunctionMar 20, 2026Low Test Results

  THE CUSTOMER OBSERVED A FALSE DEPRESSED ALINITY I CA 125 II RESULT FOR A 70-YEAR-OLD FEMALE PATIENT THAT HAS BEEN DIAGNOSED WITH OVARIAN CANCER. THE FOLLOWING RESULTS WERE PROVIDED: (LAB REFERENCE RANGE FOR CA125 <35 KU/L) (B)(6) 2026, SID (B)(6) INITIAL RESULT = 10 KU/L, (B)(6) 2026 REPEAT RESULT = 899 KU/L, RESULT AFTER 1:10 DILUTION = 1008 KU/L . NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24647581 ↗
• MalfunctionMar 9, 2026False Positive Result

  THE CUSTOMER OBSERVED FALSE REPEAT REACTIVE ALINITY S HTLV I/II RESULTS FOR MULTIPLE DONOR SAMPLES THAT WERE WESTERN BLOT NEGATIVE. THE FOLLOWING INFORMATION WAS OBTAINED; HOWEVER, NO SPECIFIC DONOR RESULTS WERE PROVIDED. ALL RESULTS WERE INITIAL REACTIVE, REPEAT REACTIVE, AND WESTERN BLOT NEGATIVE. SIDS ON INSTRUMENT (B)(6): SAMPLE ID (B)(6) - (B)(6) 2026, SAMPLE ID (B)(6)- (B)(6) 2026, SAMPLE ID (B)(6) - (B)(6) 2026, SAMPLE ID (B)(6) - (B)(6) 2026, SAMPLE ID (B)(6) - (B)(6) 2026, SAMPLE ID (B)(6) - (B)(6) 2025, SAMPLE ID (B)(6) - (B)(6) 2025, SAMPLE ID (B)(6) - (B)(6) 2025, SAMPLE ID (B)(6) - (B)(6) 2025. SID ON INSTRUMENT (B)(6): SAMPLE ID (B)(6) - (B)(6) 2026 . NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24552155 ↗
• MalfunctionMar 4, 2026High Test Results

  THE CUSTOMER OBSERVED ELEVATED ALINITY I INSULIN RESULTS. (B)(6) 2025: C-PEPTIDE: 22.2 NG/ML, INSULIN: 28.08 UU/ML, GLUCOSE: 117 (NO UNIT OF MEASUREMENT PROVIDED). (B)(6) 2025: C-PEPTIDE: 43.96 NG/ML, INSULIN: 225.7 UU/ML, GLUCOSE: 131. ROCHE ECLIA METHOD: C-PEPTIDE: 38.8 NG/ML, INSULIN: 247.1 UU/ML. (B)(6) 2026: SID (B)(6): C-PEPTIDE: 4.12 NG/ML, INSULIN: 6.4 UU/ML, GLUCOSE: 106. THE PATIENT IS 77-YEAR-OLD, MALE, WITH NO ABNORMALITIES IN GLUCOSE METABOLISM, AND CURRENTLY UNDERGOING TREATMENT FOR STOMACH CANCER, WITH TOTAL GASTRECTOMY PERFORMED IN (B)(6). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24507152 ↗
• MalfunctionMar 4, 2026High Test Results

  THE CUSTOMER REPORTED FALSELY ELEVATED ALINITY C CALCIUM RESULTS FOR MULTIPLE SAMPLES. THE FOLLOWING DATA WAS PROVIDED (UNITS OF MEASURE IS MMOL/L, CUSTOMER REFERENCE RANGE IS 2.1 TO 2.6 MMOL/L): SID (B)(6): INITIAL RESULT = 3.41, REPEATS = 3.82, 2.60, 2.60, 2.69 SID (B)(6): INITIAL RESULT = 5.57, REPEATS = 2.41, 2.42 SID (B)(6): INITIAL RESULT = 4.60, REPEATS = 2.39, 2.41 THE CUSTOMER IS QUESTIONING THE FIRST REPEAT RESULT FOR SID (B)(6) AND THE INITIAL RESULTS FOR THE OTHER SIDS. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24505805 ↗
• MalfunctionFeb 25, 2026Low Test Results

  THE CUSTOMER OBSERVED A FALSELY DECREASED ALINITY C CREATINE KINASE RESULT FOR ONE 13-YEAR-OLD PATIENT. THE LOW RESULT WAS NOT REPORTED. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S REFERENCE RANGE IS 29-200 U/L): SID (B)(6) PROCESSED ON (B)(6) 2026 INITIAL RESULT WAS 576 WITH DILUTION. REPEAT RESULT = 5993 U/L THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24443042 ↗
• MalfunctionFeb 20, 2026High Test Results

  THE CUSTOMER OBSERVED A FALSELY ELEVATED CALCIUM RESULT GENERATED ON THE ALINITY C PROCESSING MODULE FOR A 60-YEAR-OLD MALE PATIENT SAMPLE. THE FOLLOWING DATA WAS PROVIDED FOR ONE SAMPLE (CUSTOMER¿S REFERENCE RANGE 2.15-2.51 MMOL/L): SAMPLE ID (B)(6): (B)(6) 2026 INITIAL RESULT = 3.87 MMOL/L (B)(6) 2026 NEW SAMPLE OBTAINED. SAMPLE ID (B)(6) RESULT = 2.42 MMOL/L, IONIZED CALCIUM RESULT = 1.27 MMOL/L (NORMAL RANGE 1.15-1.29 MMOL/L) (B)(6) 2026 NEW SAMPLE OBTAINED AND RESULT WITH DIFFERENT LOT = 2.39 MMOL/L . THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR EVALUATION, HOWEVER, NO FURTHER IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24400211 ↗
• MalfunctionFeb 17, 2026False Positive Result

  THE CUSTOMER REPORTED FALSE REACTIVE ALINITY S HIV AG/AB COMBO RESULTS, SINCE STARTING USING REAGENT LOT 77548BE00 ON THE ALINITY S SYSTEM. THE CUSTOMER STATED SAMPLES IN QUESTION WERE SENT FOR CONFIRMATORY TESTING AND THE RESULTS CAME BACK NONREACTIVE USING THE GEENIUS HIV-1/2 SUPPLEMENTAL ASSAY. THE FOLLOWING DATA WAS PROVIDED (REFERENCE RANGE: < 1.00 S/CO NONREACTIVE, >/= 1.00 S/CO REACTIVE): ON (B)(6) 2026: (B)(4): INITIAL RESULT = 1.32 S/CO; REPEAT RESULT = 1.31 AND 1.34 S/CO. ON (B)(6) 2026: (B)(4): INITIAL RESULT = 1.05 S/CO; REPEAT RESULT = 1.00 AND 1.01 S/CO. (B)(4): INITIAL RESULT = 2.29 S/CO; REPEAT RESULTS = 2.36 AND 2.40 S/CO. ON (B)(6) 2026: (B)(4): INITIAL RESULT = 1.16 S/CO; REPAT RESULT = 1.00 S/CO. ON (B)(6) 2026: (B)(4): INITIAL RESULT = 2.23 S/CO; REPEAT RESULT = 2.14 AND 1.89 S/CO. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24370331 ↗
• MalfunctionFeb 17, 2026Low Test Results

  THE CUSTOMER OBSERVED DEPRESSED ALINITY C TOTAL BILIRUBIN RESULTS. ON (B)(6) 2026, SID (B)(6) (2 DAY OLD, MALE) GENERATED ALINITY C TOTAL BILIRUBIN INITIAL RESULT OF 0.4 MG/DL, AND THE RESULT WAS RELEASED. THE RESULT WAS QUESTIONED BY THE PROVIDED. THE SAME SAMPLE WAS REPEATED ON A DIFFERENT ALINITY PROCESSING MODULE 30 MINUTES LATER WITH RESULTS OF 18.6, 18.6 MG/DL. THE SAMPLE REPEATED AGAIN ON THE ORIGINAL ALINITY PROCESSING MODULE OF 18.7 MG/DL. A CORRECTED REPORT SENT OUT TO PROVIDER OF 18.6 MG/DL. THE CUSTOMER DOES NOT HAVE NORMAL RANGE FOR <7 DAYS OLD. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24369495 ↗

Other Abbott GmbH products

• ARCHITECT48 models · 526 reports · 8 recalls