CELL-DYNRecalls & reported problems across all models

We found 12 models of CELL-DYN by Abbott Laboratories in the FDA's device registry (GUDID). Together they are named in 918 adverse event reports in the FDA's MAUDE database, received between Aug 1, 2016 and Sep 4, 2026 — classified as 18 injuries, 900 malfunctions.

The most frequently reported specific device problem is “Low Test Results” (562 reports).

6 FDA recall records name at least one of these models by its device identifier, 6 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

CELL-DYN 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. Mar 18, 2025Open, Classified

   When expired reagents are scanned or manually entered, the system will change the expiration date to current or future date without notifying user that an expired reagent is being used. Use of expired reagents is against the guidelines of the Operator's Manual.

   Z-1656-2025 · Root cause: Software change control · Recall details · FDA record ↗

2. Mar 18, 2025Open, Classified

   When expired reagents are scanned or manually entered, the system will change the expiration date to current or future date without notifying user that an expired reagent is being used. Use of expired reagents is against the guidelines of the Operator's Manual.

   Z-1655-2025 · Root cause: Software change control · Recall details · FDA record ↗

3. Mar 18, 2025Open, Classified

   When expired reagents are scanned or manually entered, the system will change the expiration date to current or future date without notifying user that an expired reagent is being used. Use of expired reagents is against the guidelines of the Operator's Manual.

   Z-1654-2025 · Root cause: Software change control · Recall details · FDA record ↗

4. Mar 18, 2025Open, Classified

   When expired reagents are scanned or manually entered, the system will change the expiration date to current or future date without notifying user that an expired reagent is being used. Use of expired reagents is against the guidelines of the Operator's Manual.

   Z-1653-2025 · Root cause: Software change control · Recall details · FDA record ↗

5. Mar 18, 2025Open, Classified

   When expired reagents are scanned or manually entered, the system will change the expiration date to current or future date without notifying user that an expired reagent is being used. Use of expired reagents is against the guidelines of the Operator's Manual.

   Z-1652-2025 · Root cause: Software change control · Recall details · FDA record ↗

6. Oct 19, 2023Open, Classified

   The devices contain a dry natural rubber (latex) subcomponent, which are not labeled as containing dry natural rubber(latex).

   Z-0604-2024 · Root cause: Under Investigation by firm · names 2 of these models · Recall details · FDA record ↗

Most reported CELL-DYN problems

CELL-DYN models

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

• CELL-DYN 08H67-01

  Counter, differential cell
  6 recalls269 reports
• CELL-DYN 09H46-02

  DETERGENT
  387 reports
• CELL-DYN 08H00-01

  Counter, differential cell
  1 recall90 reports
• CELL-DYN 09H39-01

  Counter, differential cell
  123 reports
• CELL-DYN 08H67-03

  Counter, differential cell
  11 reports
• CELL-DYN 04R1301

  Counter, differential cell
  9 reports
• CELL-DYN 07H77-01

  Counter, differential cell
  8 reports
• CELL-DYN 08H00-03

  Counter, differential cell
  7 reports
• CELL-DYN 09H5901

  Counter, differential cell
  5 reports
• CELL-DYN 02H31-01

  Counter, differential cell
  4 reports
• CELL-DYN 02H31-03

  Counter, differential cell
  3 reports
• CELL-DYN 02H30-01

  Counter, differential cell
  2 reports

Recent CELL-DYN adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 4, 2026Low Test Results

  The customer observed falsely decreased hemoglobin (Hgb) results by the CELL DYN Ruby analyzer for a 82yrs old female patient. The results provided were:On (b)(6)2026 SID (b)(6) Hemoglobin: Initial=6.44 g/dL /repeated=6.31 g/dL.Redrawn and repeated SID (b)(6) =10.1 g/dL.On (b)(6)2026=9.4 g/dL.ON (b)(6)2026=10.2 g/dL.On (b)(6)2026=11.0 g/dL.ON (b)(6)2026=12.3 g/dL.On (b)(6)2026=10.7 g/dL.There was no reported impact to patient management.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50601572 ↗
• MalfunctionSep 2, 2026Low Test Results

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50568805 ↗
• MalfunctionMar 31, 2026Low Test Results

  THE CUSTOMER OBSERVED FALSELY DEPRESSED WHITE BLOOD CELL (WBC) VALUES GENERATED ON A CELL-DYN SAPPHIRE. AFTER AN INTERVAL WITHOUT MEASUREMENTS, WBC WOULD BE ZERO AND PLATELETS WOULD ALSO BE SLIGHTLY LOW, RUNNING A SECOND TIME WOULD PRODUCE RESULTS WITH NO ISSUES. NO ACTUAL DATA HAD BEEN PROVIDED AT THAT TIME. THE CUSTOMER REPLACED THE PERISTALTIC PUMP, BUT CONTINUED TO SEE FALSELY DEPRESSED WBC AND ABSOLUTE NEUTROPHILS FOR ONE PATIENT SAMPLE. ON 13MAR2026, SID 52600016939 INITIAL WBC RESULT = 0.130 10E3/UL, REPEAT RESULT = 9.08 10E3/UL; INITIAL SEG = 0.013 10E3/UL, REPEAT RESULT = 7.19 10E3/UL. THERE WAS NO IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24746353 ↗
• MalfunctionMar 26, 2026Smoking

  THE CUSTOMER HEARD AN EXPLOSION/LOUD BANG, SMELLED A BURNING ODOR, AND OBSERVED SMOKE COMING OUT OF THE CELL-DYN RUBY ANALYZER. THE INSTRUMENT SHUT DOWN AND THE CUSTOMER IMMEDIATELY DISCONNECTED THE INSTRUMENT. THERE WAS NO VISIBLE EVIDENCE SHOWING SIGNS OF FIRE ON THE OUTSIDE OF THE CELL-DYN RUBY ANALYZER. ADDITIONALLY, THE CUSTOMER REPORTED THERE WAS NO HARM WHATSOEVER TO THE USERS OR THE FACILITIES IN THE LABORATORY. FURTHER INFORMATION WAS PROVIDED THAT DURING THE VISUAL INSPECTION; THERE WAS EVIDENCE INDICATING THAT THE CAUSE WAS THE LAMBDA POWER SUPPLY WHICH WAS THEN REPLACED. IT WAS CONFIRMED THAT THE INSTRUMENT NO LONGER OVERHEATED OR SHUT DOWN. BACKGROUNDS WERE PROCESSED WITHIN SPECIFICATIONS AND CONTROLS WERE PROCESSED WITHIN RANGE. THE INSTRUMENT WAS DELIVERED IN GOOD WORKING ORDER AND WAS APPROVED FOR ROUTINE USE. NO IMPACT TO PATIENT MANAGEMENT OR IMPACT TO USER SAFETY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24698343 ↗
• MalfunctionMar 16, 2026Low Test Results

  THE CUSTOMER OBSERVED IMPRECISE HEMOGLOBIN RESULTS ON A CELL-DYN RUBY ANALYZER FOR ONE SAMPLE. THE FOLLOWING RESULTS WERE PROVIDED: REP 1 HGB = 8.38. REP 2 HGB = 12.7. REP 3 HGB = 5.94. REP 4 HGB = 8.25. REP 5 HGB = 7.98 THE SAMPLE WAS REPEATED ON ANOTHER INSTRUMENT GENERATING A HGB RESULT OF 13.6 THERE WAS NO IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24605232 ↗
• InjuryDec 22, 2025Use of Device Problem; Use of Device Problem

  WHILE WORKING ON A CELL-DYN RUBY ANALYZER, AN INDIVIDUAL MADE CONTACT WITH A SAMPLE PROBE. THE CONTACT CUT THROUGH THE GLOVE THE INDIVIDUAL WAS WEARING AND CAUSED A SMALL CUT ON THE RIGHT INDEX FINGER. THE INDIVIDUAL HAD THEIR BLOOD DRAWN AND WAS PROVIDED THE FOLLOWING REGIMEN OF ANTI-RETROVIRAL THERAPY (TENOFOVIR 300MG, DOLUTEGRAVIR 50MG + LAMIVUDINE 300MG) TO TAKE DAILY INITIALLY FOR 3 DAYS. THERE WAS NO FURTHER USER IMPACT REPORTED.

  Patient problems: Needle Stick/Puncture

  MAUDE report 23864387 ↗
• MalfunctionNov 20, 2025Computer Software Problem; Computer Software Problem

  THE CUSTOMER STATED THAT PATIENT SAMPLE RESULTS ARE INTERMITTENTLY BEING RECOGNIZED AS CONTROL H WHEN GENERATED ON THE CELL DYN SAPPHIRE. THE CUSTOMER WOULD SCAN THE BARCODE OF THE PATIENT SAMPLE, AND THE BARCODE NUMBER DISPLAYED ON THE SCREEN OF THE INSTRUMENT IS CORRECT, HOWEVER THE SAMPLE IS RECOGNIZED AS CONTROL H. THE CUSTOMER WOULD REPEAT TESTING ON THE SAME SAMPLE, AND THE SAMPLE IS RECOGNIZED AS A PATIENT SAMPLE AND NOT A CONTROL. THERE WERE NO DISCREPANT RESULTS REPORTED. THERE WAS NO ISSUE WITH QC AND NO FLAGS OR ERROR MESSAGES GENERATED. THE FIELD SERVICE ENGINEER (FSE) ARRIVED ONSITE TO INSPECT THE CELL DYN SAPPHIRE AND FOUND THAT THE DEFAULT SETTING FOR THE HOST MEASUREMENT REQUEST WAS ¿QC¿. THEREFORE, WHEN THERE IS A COMMUNICATION ISSUE SUCH AS A QUERY TIMEOUT, THE INSTRUMENT AUTOMATICALLY RECOGNIZES THE SAMPLE AS A QC SAMPLE. THE DEFAULT SETTING WAS CHANGED FOR THE MEASUREMENT REQUEST TO ¿PATIENT SAMPLE¿. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23611690 ↗
• MalfunctionNov 4, 2025Sparking; Sparking

  DURING INSTALLATION OF THE CELL-DYN EMERALD THE ABBOTT FIELD SERVICE ENGINEER (FSE) CONNECTED THE PRINTER, UPS AND BARCODE READER. WHEN THEY THEN POWERED ON THE ANALYZER THEY OBSERVED A LARGE SPARK. THE UPS, CELL-DYN EMERALD AND PRINTER WERE NON-FUNCTIONAL AFTER THIS OCCURRED. NO IMPACT TO PATIENT MANAGEMENT OR USER SAFETY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23464581 ↗
• MalfunctionOct 23, 2025High Test Results; High Test Results

  THE CUSTOMER OBSERVED A FALSELY ELEVATED WBC RESULT GENERATED ON THE CELL-DYN RUBY FOR A PATIENT SAMPLE. THE FOLLOWING DATA WAS PROVIDED: SAMPLE ID (B)(6), INITIAL RESULT = 60.7 10E3/UL, REPEAT RESULT = 15.1 10E3/UL . NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23372831 ↗
• MalfunctionSep 16, 2025High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED PLATELET RESULTS GENERATED ON THE CELL DYN RUBY ANALYZER AFTER IT ENTERS A PROLONGED IDLE STATE. THE FOLLOWING DATA WAS PROVIDED (REFERENCE VALUES PLT 150-450 10E3/UL; RBC 4.2-5.4 10E6/UL; WBC 5-10 10E3/UL): PATIENT 1 SID (B)(6) 03/09/2025 7:04. WBC 6.24 10E3/UL. RBC 1.88 10E6/UL. PLT 989 10E3/UL. SID NO ID (IT IS THE SAME SAMPLE) 03/09/205 7:30. WBC 5.88 10E3/UL. RBC 2.33 10E6/UL. PLT 570 10E3/UL. SID (B)(6) 03/09/2025 7:44. WBC 9.65 10E3/UL. RBC 3.40 10E6/UL. PLT 323 10E3/UL. PATIENT 2 SID (B)(6) 03/09/2025 3:37. WBC 5.25 10E3/UL. RBC 2.12 10E6/UL. PLT 984 10E3/UL. SID NO ID (IT IS THE SAME SAMPLE) 03/09/205 3:40. WBC 5.17 10E3/UL. RBC 3.08 10E6/UL. PLT 277 10E3/UL. SID (B)(6) 03/09/2025 3:42. WBC 5.56 10E3/UL RBC 3.20 10E6/UL. PLT 285 10E3/UL. PATIENT 3 SID (B)(6) 02/09/2025 6:50. PLT 1055 10E3/UL RBC 1.56 10E6/UL WBC 5.88 10E3/UL SID (B)(6) 02/09/2025 7:01. PLT 341 10E3/UL RBC 2.57 10E6/UL WBC 6.27 10E3/UL SID (B)(6) 02/09/2025 7:08. PLT 336 10E3/UL RBC 2.57 10E6/UL WBC 6.15 10E3/UL SID (B)(6) 02/09/2025 7:11. PLT 1016 10E3/UL RBC 1.67 10E6/UL WBC 6.42 10E3/UL SID (B)(6) 02/09/2025 7:14. PLT 663 10E3/UL RBC 2.06 10E6/UL WBC 6.03 10E3/UL SI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23067259 ↗
• InjuryAug 15, 2025Leak/Splash; Leak/Splash

  THE ABBOTT TECHNICIAN WAS PERFORMING PREVENTATIVE MAINTENANCE ON THE CELL DYN RUBY ANALYZER AND WAS SPLASHED IN THE EYE WHEN CHANGING THE HEMOGLOBIN REAGENT SYRINGE. THE TECHNICIAN WAS NOT WEARING GOGGLES. SHE FLUSHED HER EYES WITH WATER AND WENT TO THE CLINIC TO GET MEDICAL CARE. THE TECHNICIAN WAS GIVEN EYE DROPS FOR TREATMENT (MOXIFLOXACINA 0.5% HYLO GEL EYES DROPS). THERE WAS NO REPORTED IMPACT TO PATIENT RESULTS OR PATIENT MANAGEMENT. THE TECHNICIAN WAS GIVEN EYE DROPS FOR TREATMENT (MOXIFLOXACINA 0.5% HYLO GEL EYES DROPS).

  Patient problems: Eye Injury

  MAUDE report 22814280 ↗
• InjuryJun 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FIELD SERVICE REPRESENTATIVE (FSR) WAS ONSITE TROUBLESHOOTING INSTRUMENT ERROR MESSAGES ON THE CELL DYN RUBY ANALYZER AND IDENTIFIED THE MIXER HEAD HAD A LEAK. DURING REPLACEMENT OF A SPARE PART, THE FSR WAS PUNCTURED WITH THE SAMPLE PROBE. HE IMMEDIATELY WASHED THE AREA WITH SOAP, APPLIED PRESSURE TO THE LACERATION, AND CLEANED IT WITH AN ANTISEPTIC WIPE. THE FSR WAS TREATED IN THE EMERGENCY DEPARTMENT AND WAS PRESCRIBED A ONE MONTH COURSE OF ANTI-RETROVIRAL THERAPY. NO ADDITIONAL IMPACT/TREATMENT TO THE FIELD SERVICE REPRESENTATIVE WAS REPORTED.

  Patient problems: Needle Stick/Puncture

  MAUDE report 22358625 ↗
• MalfunctionJun 16, 2025Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED A FALSELY DEPRESSED HEMOGLOBIN CELL-DYN RUBY RESULTS FOR ONE PATIENT. THE RESULT WAS HIGHER WHEN REPEATED ON THE SAME INSTRUMENT. THE FOLLOWING DATA WAS PROVIDED: RUBY SERIAL NUMBER (B)(6), SID (B)(6), PROCESSED ON (B)(6) 2025: RESULTS FROM 7:54 AM: HEMOGLOBIN = 7.12 G/DL. OTHER RESULTS: RBC = 206 10E4/UL, MCV = 106, WBC = 95.5 10E2/UL, PLT = 27.4 10E4/UL. RESULTS FROM 8:45 AM NEW SAMPLE SAME PATIENT: HEMOGLOBIN = 8.90 G/DL. OTHER RESULTS: RBC = 260, MCV = 107, WBC = 84.6, PLT = 23.3. RESULTS FROM 9:37 AM NEW SAMPLE SAME PATIENT: HEMOGLOBIN = 9.60 G/DL. OTHER RESULTS: RBC = 283, MCV = 105, WBC = 71.7, PLT = 22.1 THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22212672 ↗
• MalfunctionJun 16, 2025Leak/Splash; Leak/Splash

  THE CUSTOMER OBSERVED AN ASTERISK (*) AND A SHORT SAMPLE MESSAGE FOR ALL SAMPLES GENERATED ON THE CELL-DYN SAPPHIRE ANALYZER. THE HBG CUP AND RBC CUP DID NOT DRAIN AND REPORTED THE WASH CUP (WC) #4 AND WC #3 WAS FULL. THE CUSTOMER REPORTED TWO USERS WERE SPRAYED IN THE FACE WITH LIQUID FROM THE LEFT FLOW PANEL WHILE OBSERVING. THE CUSTOMER MENTIONED THE USERS DID NOT TAKE ANY ACTIONS AFTER BEING SPRAYED IN THE FACE WITH THE LIQUID. NO IMPACT TO PATIENT MANAGEMENT OR IMPACT TO USER SAFETY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22211362 ↗
• MalfunctionMay 28, 2025High Test Results; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED HEMOGLOBIN RESULTS ON THE CELL DYN EMERALD ANALYZER FOR ONE PATIENT. THE FOLLOWING RESULTS WERE PROVIDED (REFERENCE RANGE 13.5 TO 18 G/DL): HEMOGLOBIN RESULT (CELL DYN EMERALD)= 10 G/DL AND 12 G/DL; HEMOGLOBIN RESULT (CELL DYN RUBY)= 6.5 G/DL, 5.5 G/DL. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22096240 ↗

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