SynchronRecalls & reported problems across all models

We found 7 models of Synchron by Beckman Coulter, Inc. in the FDA's device registry (GUDID). Together they are named in 4 adverse event reports in the FDA's MAUDE database, received between Mar 2, 2017 and Dec 19, 2018 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Low Test Results” (3 reports).

5 FDA recall records name at least one of these models by its device identifier, 2 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

Synchron 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. Sep 3, 2025Open, Classified

   Specific SYNCHRON Systems Modular Chemistry Phosphorus (PHOSm REF 467868) reagent lots may fail calibration before the lot expiration date which causes a delay in obtaining patient results.

   Z-0071-2026 · Root cause: Unknown/Undetermined by firm · Recall details · FDA record ↗

2. Nov 10, 2021Open, Classified

   Cholesterol Reagent may fail with Out of Calibration Range Low (OCR Low) and/or Back to Back (B/B) errors. Low quality control recovery failures may be observed after passing calibration. Brown particulates in compartment C of the reagent cartridge may be observed. Continued use may lead to, 1) failed QC and/or calibrations, 2) Erroneous low Cholesterol patient results.

   Z-0399-2022 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

3. Sep 4, 2019Terminated

   Cross-reactivity testing may not meet the claims indicated in the Opiate 300 ng (OP)Instructions For Use. The presence of certain compounds in urine may result in false positive or false negative patient test results.

   Z-1752-2020 · Root cause: Material/Component Contamination · Recall details · FDA record ↗

4. Sep 4, 2019Terminated

   Cross-reactivity testing may not meet the claims indicated in the Opiate 2000 ng (OP2) Instructions For Use. The presence of certain compounds in urine may result in false positive or false negative patient test results.

   Z-1751-2020 · Root cause: Material/Component Contamination · Recall details · FDA record ↗

5. Jun 12, 2019Terminated

   The firm has identified that cross-reactivity testing may not meet the claims indicated in the Barbiturates Reagent Chemistry Information Sheet (CIS). The presence of certain compounds in urine may result in false positive or false negative results.

   Z-1799-2020 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported Synchron problems

Synchron models

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

• Synchron 475006

  Enzyme Immunoassay, Opiates
  1 recall0 reports
• Synchron 475024

  Enzyme Immunoassay, Opiates
  1 recall0 reports
• Synchron 475012

  Enzyme Immunoassay, Barbiturate
  1 recall0 reports
• Synchron 467868

  Phosphomolybdate (Colorimetric), Inorganic Phosphorus
  1 recall0 reports
• Synchron 467825

  Enzymatic Esterase--Oxidase, Cholesterol
  1 recall0 reports
• Synchron 471288

  Calibrator, Multi-Analyte Mixture
  2 reports
• Synchron 476861

  Diazo Colorimetry, Bilirubin
  2 reports

Recent Synchron adverse event reports

The 4 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionDec 19, 2018Low Test Results; Low Test Results

  THE CUSTOMER REPORTED RECEIVING ERRONEOUS LOW PATIENT RESULTS FOR TOTAL BILIRUBIN (TBIL) ON THE UNICEL DXC 660I SYNCHRON ACCESS CLINICAL SYSTEM. THE ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LAB. THERE WAS NO CHANGE IN PATIENT TREATMENT IN ASSOCIATION WITH THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8182708 ↗
• MalfunctionSep 20, 2018Low Test Results; Low Test Results

  THE CUSTOMER REPORTED ERRONEOUSLY LOW SODIUM (NA) RESULTS ON THEIR UNICEL DXC 600 PRO SYNCHRON SYSTEM. THE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. THE CUSTOMER STATED THAT QUALITY CONTROL (QC) RECOVERED WITHIN SPECIFICATIONS PRIOR TO THE EVENT. THERE WAS NO CHANGE TO PATIENT TREATMENT IN ASSOCIATION WITH THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7896408 ↗
• MalfunctionJan 26, 2018Low Test Results; Low Test Results

  THE CUSTOMER STATED ERRONEOUSLY LOW NA (SODIUM) PATIENT RESULTS WERE GENERATED ON THEIR UNICEL DXC 600 PRO SYNCHRON SYSTEM USING AQUA CALIBRATOR LEVEL LOT 72853811. THE CUSTOMER STATED THE PATIENT SAMPLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY, HOWEVER THE RESULTS WERE AMENDED/CORRECTED WITH NO CHANGE TO PATIENT TREATMENT. A REVIEW OF THE CUSTOMER PROVIDED DATA CONFIRMS THE INSTRUMENT GENERATED 1 (ONE) ERRONEOUSLY LOW NA PATIENT RESULT. A REVIEW OF THE NA QUALITY CONTROL (QC) DATA PROVIDED SHOWS RECOVERIES FOR LEVEL 2 WERE GREATER THAN 2SD LOW OF THE INSTRUMENT CONTROL MEAN ON THE EVENT DATE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7222202 ↗
• MalfunctionMar 2, 2017Incorrect Or Inadequate Test Results; Incorrect Or Inadequate Test Results

  THE CUSTOMER STATED ERRONEOUS DBIL (DIRECT BILIRUBIN) AND TBIL (TOTAL BILIRUBIN) PATIENT RESULTS WERE GENERATED ON THEIR UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM. THE CUSTOMER STATED THE PATIENT SAMPLE RESULTS WERE NOT REPORTED OUTSIDE OF THE LABORATORY AND THERE WAS NO IMPACT TO PATIENT TREATMENT. THE TBIL AND DBIL QUALITY CONTROL (QC) RECOVERIES WERE WITHIN INSTRUMENT CONTROL RECOVERIES DURING THE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6375163 ↗

Other Beckman Coulter, Inc. products

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