Alinity 08P4320Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00380740135591), received between Jun 28, 2022 and Aug 2, 2022 — classified as 7 malfunctions.

The most frequently reported specific device problem is “High Test Results” (7 reports).

1 FDA recall record name this device's identifier, 1 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, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. 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 · FDA record ↗

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 2, 2022High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED ALINITY C HEMOGLOBIN A1C RESULT FOR ONE PATIENT SAMPLE THAT WAS QUESTIONED BY THE PHYSICIAN. THE SAMPLE WAS REPEATED, AND THE RESULT WAS NORMAL. THE FOLLOWING DATA WAS PROVIDED (NORMAL RANGE: < 6.5%): SID (B)(6) INITIAL RESULT = > 14%, REPEAT RESULT = 6.3%. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15145045 ↗
• MalfunctionJul 8, 2022High Test Results; High Test Results

  THE CUSTOMER OBSERVED A FALSELY ELEVATED ALINITY C HEMOGLOBIN A1C RESULT FOR ONE PATIENT. THE FOLLOWING DATA WAS PROVIDED: SAMPLE ID (B)(6) RESULT WAS 129.5 MMOL/MOL, WHICH WAS REPORTED TO THE PHYSICIAN. THE PATIENT¿S PREVIOUS RESULT, IN JANUARY, WAS 42 MMOL/MOL. BASED ON THE ELEVATED HEMOGLOBIN A1C RESULT, THE PATIENT HAS BEEN TREATED; HOWEVER, NO OTHER INFORMATION WAS PROVIDED. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14955385 ↗
• MalfunctionJul 8, 2022High Test Results; High Test Results

  THE CUSTOMER OBSERVED A FALSELY ELEVATED ALINITY C HEMOGLOBIN A1C RESULT FOR ONE PATIENT. THE FOLLOWING DATA WAS PROVIDED: INITIAL RESULT WAS ¿UNDETECTABLE¿, REPEATED, IN THE MAIN LAB, WAS 13.8%. THE SAMPLE WAS REPEATED, ON ANOTHER PLATFORM, AND THE RESULT WAS 4.6%, WHICH AGREED WITH THE GLUCOSE RESULT OF 5.2 MMOL/L. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14955343 ↗
• MalfunctionJun 28, 2022High Test Results; High Test Results

  THE CUSTOMER STATED THAT A FALSELY ELEVATED ALINITY C HEMOGLOBIN A1C RESULT WAS GENERATED FOR A PATIENT ON (B)(6) 2022. THE FOLLOWING DATA WAS PROVIDED. SAMPLE NUMBER: (B)(4). HBA1CWB: 63.7512 UMOL/L. THBWB: 83.3212 UMOL/L. %A1CWB: >14.00%. THE PATIENT HAS A KNOWN HISTORY OF DIABETES AND HAS AN INSULIN PUMP. THE PHYSICIAN QUESTIONED THE RESULT BECAUSE THE PATIENT HAS A HISTORY OF STABLE %A1CWB VALUES. IT WAS SUSPECTED THAT THE PUMP WAS POSSIBLY NOT WORKING CORRECTLY SINCE THE ELEVATED RESULT WAS NOT EXPECTED. THE SAME SAMPLE WAS RETESTED ON (B)(6) 2022 WITH THE FOLLOWING RESULTS. HBA1CWB: 236.1069 UMOL/L. THBWB: 4179.2451 UMOL/L. %A1CWB: 7.32%. REVIEW OF INSTRUMENT LOGS SHOWED A DIFFERENT ASPIRATION CURVE FOR THE FALSELY ELEVATED RESULT INDICATING A POTENTIAL SAMPLE ISSUE SUCH AS A CLOT. THE CUSTOMER WILL BE IMPLEMENTING A NEW RETEST RULE FOR EVERY A1CWB ABOVE 11.3%. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14844031 ↗
• MalfunctionJun 28, 2022High Test Results; High Test Results

  THE CUSTOMER OBSERVED DISCREPANT ALINITY C HEMOGLOBIN A1C RESULTS ON MULTIPLE PATIENT SAMPLES THAT WERE NORMAL UPON REPEAT ON THE ALINITY ANALYZER AND VARIANT (HPLC). THE FOLLOWING DATA WAS PROVIDED: (B)(6) 2022. SID (B)(6) INITIAL %HBA1C RESULT = > 14.0%, REPEAT = 5.70%, VARIANT (HPLC) = 6.20%, SID (B)(6) INITIAL %HBA1C RESULT = > 14.0 %, REPEAT = 7.90%, VARIANT (HPLC) = 9.30%, SID (B)(6) INITIAL %HBA1C RESULT = > 14.0%, REPEAT = 7.40%, VARIANT (HPLC) = 4.50%, SID (B)(6) INITIAL %HBA1C RESULT = > 14.0%, REPEAT = 6.90%, VARIANT (HPLC) = 7.10%. (B)(6) 2022. SID (B)(6) INITIAL %HBA1C RESULT = > 14.0%, REPEAT = > 14%, VARIANT (HPLC) = 4.20%, SID (B)(6) INITIAL %HBA1C RESULT = > 14.0%, REPEAT = 5.60%, VARIANT (HPLC) = 6.00%, SID (B)(6) INITIAL %HBA1C RESULT = > 14.0%, REPEAT = 6.20%, VARIANT (HPLC) = 6.20%. (B)(6) 2022 . SID (B)(6) INITIAL %HBA1C RESULT = > 14.0%, REPEAT = 6.00%, VARIANT (HPLC) = 6.40%, SID (B)(6) INITIAL %HBA1C RESULT = > 14.0%, REPEAT = 8.00%, VARIANT (HPLC) = 7.80%, SID (B)(6) INITIAL %HBA1C RESULT = > 14.0%, REPEAT = 7.30%, VARIANT (HPLC) = 7.40%, SID (B)(6) INITIAL %HBA1C RESULT = > 14.0%, REPEAT = 6.60%, VARIANT (HPLC) = 6.60%, SID (B)(6) INITIAL %HBA1C RESULT =

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14843108 ↗
• MalfunctionJun 28, 2022High Test Results; High Test Results

  THE CUSTOMER REPORTED FALSELY ELEVATED HEMOGLOBIN A1C RESULTS GENERATED ON THE ALINITY C ANALYZER ON MULTIPLE PATIENTS. EXAMPLE SIDS PROVIDED: (B)(6). THE CUSTOMER OBSERVES > 129 MMOL/ML AND UPON REPEAT THE RESULTS ARE NORMAL. RESULTS PROVIDED: SID (B)(6). FIRST RUN >129.51 MMOL/MOL / >129.51 MMOL/MOL. 1RST RERUN 38.89 MMOL/MOL / 56.33 MMOL/MOL. 2ND RERUN 38.44 MMOL/MOL / 56.23 MMOL/MOL. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14842667 ↗
• MalfunctionJun 28, 2022High Test Results; High Test Results

  THE CUSTOMER OBSERVED A FALSELY ELEVATED ALINITY C HEMOGLOBIN A1C RESULT FOR ONE PATIENT. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S NORMAL REFERENCE RANGE IS <5.7%): SAMPLE ID (B)(6) INITIAL HBA1CWB RESULT WAS 53.5221, THBWB RESULT WAS 461.0438, RESULT WAS %A1CWB 12.8%, REPEAT HBA1CWB WAS 94.5087, THBWB WAS 3,240.5947, %A1CWB WAS 4.8%. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14842618 ↗