MicroScanRecalls & reported problems across all models

We found 10 models of MicroScan by Beckman Coulter, Inc. in the FDA's device registry (GUDID). Together they are named in 7 adverse event reports in the FDA's MAUDE database, received between May 22, 2015 and May 1, 2026 — classified as 1 death, 3 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (3 reports).

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

MicroScan 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. Jun 26, 2026Open, Classified

   Analyzers contain incorrect algorithms which may affect antimicrobial susceptibility test results, leading to false susceptibility classifications."

   Z-2889-2026 · Root cause: Software Design Change · Recall details · FDA record ↗

2. Jun 26, 2026Open, Classified

   Analyzers contain incorrect algorithms which may affect antimicrobial susceptibility test results, leading to false susceptibility classifications."

   Z-2888-2026 · Root cause: Software Design Change · Recall details · FDA record ↗

3. Jul 24, 2025Open, Classified

   Due to the likely presence of contamination in well(s).

   Z-1609-2026 · Root cause: Material/Component Contamination · Recall details · FDA record ↗

4. Oct 3, 2022Open, Classified

   Due to MicroScan autoSCAN-4 Instruments being manufactured with an incorrect diffuser plate.

   Z-0269-2023 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

5. Dec 2, 2020Terminated

   Due to a customer report and internal investigation, it was confirmed that a portion of the affected product lot failed quality control (QC) for ATCC E. Faecalis 29212 versus daptomycin and it is a possibility to obtain false elevated MIC for clinical isolates with daptomycin even when quality control results are within specification.

   Z-0720-2021 · Root cause: Process control · Recall details · FDA record ↗

6. Oct 21, 2019Open, Classified

   WalkAway Instruments may have been assembled with the incorrect AC power entry connector inlet with is rated at 1 ampere current rating rather than the correct current rating of 10 ampere

   Z-1086-2022 · Root cause: Mixed-up of materials/components · Recall details · FDA record ↗

7. Oct 21, 2019Open, Classified

   WalkAway Instruments may have been assembled with the incorrect AC power entry connector inlet with is rated at 1 ampere current rating rather than the correct current rating of 10 ampere

   Z-1085-2022 · Root cause: Mixed-up of materials/components · Recall details · FDA record ↗

8. Oct 21, 2019Open, Classified

   WalkAway Instruments may have been assembled with the incorrect AC power entry connector inlet with is rated at 1 ampere current rating rather than the correct current rating of 10 ampere

   Z-1084-2022 · Root cause: Mixed-up of materials/components · Recall details · FDA record ↗

9. Sep 4, 2019Terminated

   Instruments were manufactured with a shortened 30mL reagent draw straw which may result in reagents not dispensing and may lead to organism misidentification and/or Quality Control (QC) failure.

   Z-1371-2021 · Root cause: Process control · Recall details · FDA record ↗

Most reported MicroScan problems

MicroScan models

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

• MicroScan B1018-284

  Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems
  2 recalls2 reports
• MicroScan B1018-440

  Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems
  1 recall1 death2 reports
• MicroScan B1018-496

  Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems
  1 recall1 report
• MicroScan B1017-216

  Susceptibility Test Cards, Antimicrobial
  1 recall0 reports
• MicroScan B1018-280

  Colorimeter, Photometer, Spectrophotometer For Clinical Use
  1 recall0 reports
• MicroScan C42464

  Susceptibility Test Cards, Antimicrobial
  1 recall0 reports
• MicroScan V5.03 PU11E

  System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
  1 recall0 reports
• MicroScan V5.03 PU11

  System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
  1 recall0 reports
• MicroScan B1010-41A

  Gram Negative Identification Panel
  1 report
• MicroScan B1017-411

  Gram Negative Identification Panel
  1 report

Recent MicroScan adverse event reports

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

• InjuryMay 1, 2026Manufacturing, Packaging or Shipping Problem

  THE CUSTOMER IN JAPAN REPORTED ONE BOTTLE OF B1010-41A MICROSCAN KOVAC¿S REAGENT LOT 2026-11-13 ARRIVED LEAKING. THE PACKAGE ARRIVED WITH THE OUTER PACKAGING CONTAMINATED WITH THE REAGENT. UPON INSPECTION OF THE BOTTLE, IT WAS NOTED THE CAP WAS INSUFFICIENTLY TIGHTENED AND SHRINK-WRAPPED TO THE BOTTLE IN A TILTED STATE. AT THE TIME OF DISCOVERY, THE ODOR OF THE LEAKED REAGENT WAS EXTREMELY STRONG, AND TWO STAFF MEMBERS FELT UNWELL REPORTING ONGOING COLD-LIKE SYMPTOMS, EYE AND RESPIRATORY IRRITATION. ONE OF THE TWO EXPOSED STAFF MEMBERS DID SEEK OUT MEDICAL ATTENTION AND WAS PRESCRIBED MEDICATION. BOTH STAFF MEMBERS HAVE FULLY RECOVERED.

  Patient problems: Chemical Exposure

  MAUDE report 25059416 ↗
• DeathFeb 13, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER REPORTED GETTING HIGH PROBABILITY MISIDENTIFICATION (HPID) OF CITROBACTER FARMERI ON PATIENT SAMPLES USING NEG URINE COMBO 90 (NUC90, P/N C48640, LOT # 2025-11-11) PANELS PROCESSED IN THEIR DXM 1040 MICROSCAN WALKAWAY INSTRUMENT S/N (B)(6). THE CUSTOMER STATED THE MISIDENTIFICATION IMPACTED ONE PATIENT SAMPLE, MULTIPLE CULTURES. THE CUSTOMER NOTIFIED THE PHYSICIAN OF THE ERRONEOUS RESULTS OBTAINED FROM URINE SAMPLE. THE CUSTOMER STATED THE PATIENT WAS PUT ON HOSPICE AND PASSED AWAY ON (B)(6) 2025. IT WAS FURTHER NOTED THAT THE PATIENT DID NOT HAVE CAPACITY AND WAS REFUSING TREATMENT. THE PATIENT¿S FAMILY OPTED FOR COMFORT FOCUSED MEASURES. THE CUSTOMER INDICATED THEY REACHED OUT TO THEIR INTERNAL TEAM, AND THEY STATED THE MISIDENTIFICATION CAUSED A DELAY IN APPROPRIATE TREATMENT FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21381586 ↗
• MalfunctionOct 3, 2024Therapeutic or Diagnostic Output Failure; Therapeutic or Diagnostic Output Failure

  THE CUSTOMER REPORTED THE GENERATION OF HIGH PROBABILITY MISIDENTIFICATION RESULTS USING B1017-219 PC45 PANELS PROCESSED ON THEIR WALKAWAY (WA) SYSTEM (S/N: (B)(6). THE CUSTOMER STATED THAT A PATIENT ISOLATE WAS INITIALLY IDENTIFIED AS S. SHOLIFERI (BIOTYPE 313731, 99.99% PROBABILITY) USING PC45 PANEL, AND THIS IDENTIFICATION WAS REPORTED TO THE PHYSICIAN. REPEAT TESTING USING BIOFIRE AND B1017-166 RPID2 PANEL WAS PERFORMED, AND BOTH GAVE AN IDENTIFICATION OF S. AUREUS. THE UPDATED IDENTIFICATION REPORT WAS PROVIDED TO THE PHYSICIAN, AND THE PHYSICIAN HAD TO CHANGE THE PATIENT'S COURSE OF TREATMENT BASED ON THE AMENDED REPORT WITH THE CORRECT ORGANISM IDENTIFICATION, HOWEVER NO ADDITIONAL DETAILS WERE PROVIDED. THE CUSTOMER DID NOT PROVIDE PATIENT DATA OR DEMOGRAPHICS.

  Patient problems: Insufficient Information

  MAUDE report 20364584 ↗
• MalfunctionJun 2, 2020Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping

  BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) REPORTED THAT DURING THE UNPACKING OF THE DXM 1040 WALKAWAY INSTRUMENT, THE COUNTERWEIGHT, COUNTER WEIGHT ROD AND VERTICAL AXIS READ ASSEMBLY SLIPPED CAUSING A NEAR INJURY TO THE FSE DUE TO A MISSING SHAFT LOCK CLIP. THE FSE WAS NOT INJURED AS THE PACKAGING MATERIAL CAUGHT THE COUNTERWEIGHT AFTER ONLY 1-INCH SLIP.

  Patient problems: No Consequences Or Impact To Patient; No Patient Involvement; Not Applicable

  MAUDE report 10111548 ↗
• InjuryNov 6, 2019Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  CUSTOMER REPORTED ISSUES WITH LOW PROBABILITY IDENTIFICATIONS AND (B)(6) RESISTANT MISREADS WHEN COMPARED TO VISUAL READ. CUSTOMER INDICATED THEY HAD TWO SPECIMENS WHERE ERRONEOUS RESULTS WERE REPORTED. FIRST SPECIMEN REPORTED AS (B)(6). UPON REPEAT, THE ISOLATE IDENTIFIED AS (B)(6). THE (B)(6) RESULT WAS REPORTED OUT AND QUESTIONED. THE PATIENT HAD A SPECIMEN RUN SEVERAL DAYS PRIOR THAT RESULTED AS (B)(6). THE (B)(6) RESULT WAS OBTAINED ON (B)(6) 2019. PHYSICIAN BEGAN (B)(6) TREATMENT FOR THE (B)(6) YEARS OLD FEMALE DIAGNOSED WITH SEPTIC SHOCK. AFTER THE REPEAT RESULT OF (B)(6) WAS OBTAINED ON (B)(6) 2019, THE CUSTOMER INDICATED THE TREATMENT WAS GOING TO BE CHANGED TO (B)(6). SECOND SPECIMEN WAS VERY RESISTANT AND TESTED AS ESCHERICHIA COLI ESBL NEGATIVE ON (B)(6) 2019. UPON REPEAT ON (B)(6) 2019, THE ORGANISM TESTED AS ESBL NEGATIVE AGAIN BUT WAS MANUALLY EDITED TO POSITIVE BASED ON VISUAL READ OF THE PANEL. THE PATIENT WAS A (B)(6) YEARS OLD MALE WITH A URINARY TRACT INFECTION. CUSTOMER DID NOT KNOW WHAT THE INITIAL TREATMENT WAS; THE AMENDED TREATMENT WAS MEROPENEM. THERE WAS A THIRD SPECIMEN HOWEVER NO ERRONEOUS RESULTS WERE REPORTED. THE ISOLATE TESTED AS KLEBSIELLA OXYTOCA

  Patient problems: Septic Shock; Urinary Tract Infection

  MAUDE report 9287658 ↗
• InjuryAug 8, 2019Device Handling Problem; Device Handling Problem

  WHILE ONSITE ON (B)(6) 2018 CONDUCTING A REPAIR ON WALKAWAY (WA) 96 PLUS, SERIAL NUMBER (B)(4), THE BECKMAN COULTER FIELD SERVICE ENGINEER (FSE) INJURED HIS SHOULDER.

  Patient problems: Injury

  MAUDE report 8876535 ↗
• MalfunctionMay 22, 2015Incorrect, Inadequate or Imprecise Result or Readings

  Patient problems: No Patient Involvement

  MAUDE report 4793485 ↗

Other Beckman Coulter, Inc. products

• Cytomics FC5002 models · 1,337 reports
• DxC AU4 models · 632 reports · 8 recalls
• Synchron7 models · 4 reports · 5 recalls
• DxC 500i Clinical Analyzer, DxC 500i AU Chemistry Module2 models · 5 reports · 4 recalls
• UniCel DxH4 models · 74 reports · 2 recalls
• Access AccuTnI+32 models · 165 reports
• REMISOL Advance2 models · 0 reports · 2 recalls
• Access TSH (3rd IS)2 models · 7 reports · 1 recall