CELL-DYN 08H67-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 269 adverse event reports that list this exact device (DI 00380740017170), received between Sep 15, 2016 and Sep 4, 2026 — classified as 10 injuries, 259 malfunctions.

The most frequently reported specific device problem is “Pressure Problem” (105 reports).

6 FDA recall records name this device's 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, 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. 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 · 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-1654-2025 · Root cause: Software change control · 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-1652-2025 · Root cause: Software change control · 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-1655-2025 · Root cause: Software change control · 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-1653-2025 · Root cause: Software change control · 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 · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 269 reports, 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 ↗
• 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 ↗
• 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 ↗
• MalfunctionApr 22, 2025Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED A FALSELY DEPRESSED WBC ON THE CELL DYN RUBY ANALYZER FOR ONE PATIENT THAT WAS NOT REPORTED OUT OF THE LABORATORY. THE CUSTOMER REPORTED THAT THE CELL DYN ANALYZER WOULD GENERATE LOW RESULTS FOR ALL ANALYTES, BUT WHEN THE SAMPLE WAS REPEATED THE RESULTS WERE HIGHER. THE FOLLOWING RESULTS WERE PROVIDED (REFERENCE RANGE WBC 6.1 ¿ 7.6 10E3/UL): INITIAL WBC RESULT= 0.64 10E3/UL; REPEAT RESULT= 8.16 10E3/UL. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21881318 ↗
• MalfunctionMar 31, 2025Incorrect, Inadequate or Imprecise Result or Readings; High Test Results; Incorrect, Inadequate or Imprecise Result or Readings; High Test Results

  THE CUSTOMER OBSERVED FALSELY ELEVATED WBC RESULTS AND DISCREPANT HEMOGLOBIN RESULTS GENERATED BY THE CELL-DYN RUBY ANALYZER FOR A PATIENT, WHICH WERE INCONSISTENT WITH THE RESULTS FROM THE SYSMEX. THE BLOOD SMEAR WAS REVIEWED AND SHOWED THE PRESENCE OF NUCLEATED RBCS (NRBCS). THE FOLLOWING DATA WERE PROVIDED: ON (B)(6) 2025 SAMPLE ID: (B)(6) SEQUENCE#: 4570 (CBC+ RRBC TEST MODE). RUBY WBC RESULT = 92.7 X 10E3/ L (INVALIDATED WITH AN ASTERISK). RUBY HGB RESULT = 8.15 G/DL. FLAGS PRESENT: (NOC)WBC, FWBC/NWBC, DFLT (NLMEB), VAR LYM, RBC MORPH. THE CUSTOMER RELEASED THE RESULTS FROM SEQUENCE #4570 OUT OF THE LAB. UPON REVIEWING THE BLOOD SMEAR, NUMEROUS NRBCS WERE SEEN. THE SAMPLE WAS REPEATED ON THE CELL-DYN RUBY IN CBC + NOC TEST MODE AS WELL AS ON THE SYSMEX PLATFORM. THE FOLLOWING DATA WERE PROVIDED: ON (B)(6) 2025 SAMPLE ID: (B)(6) SEQUENCE#: 4571 (CBC+ NOC TEST MODE). RUBY WBC RESULT = 89.5 X 10E3/ L. RUBY HGB RESULT = 7.25 G/DL. FLAGS PRESENT: NOC, FWBC, DFLT (NLMEB), RBC MORPH. ON (B)(6) 2025 SYSMEX RESULTS: WBC = 16.31 X 10E3/ L. HGB = 5.8 G/DL. FLAGS PRESENT: WBC ABN SCATTERGRAM, LYMPHOCYTOSIS, MONOCYTOSIS, NRBC PRESENT, IG PRESENT, BLASTS/ABN LYMPHO, ANISOCYTOSIS, MACROCYTO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21729864 ↗
• MalfunctionSep 23, 2024Fire; Fire

  THE CUSTOMER STATED THAT THE POWER CABLE ON THE CELL DYN RUBY ANALYZER SUDDENLY CAUGHT FIRE. THE POWER CORD AND THE CELERON COMPUTER ASSEMBLY WERE REPLACED. THERE WAS NO VISIBLE DAMAGE TO THE INSTRUMENT, LAB AND TO ANY PERSONNEL. NO REPORT OF INJURIES/EXPOSURE OR IMPACT TO USER SAFETY AND NO IMPACT TO ANALYTICAL PATIENT RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20280034 ↗
• MalfunctionSep 19, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER OBSERVED IMPRECISE HEMOGLOBIN RESULTS GENERATED ON THE CELL DYN RUBY FOR A NEONATAL PATIENT SAMPLE. THE FOLLOWING DATA WAS PROVIDED (CUSTOMER¿S REFERENCE RANGE 12.9-14.2 G/DL): INITIAL RESULT = 16.8 G/DL, REPEAT RESULT = 6.75 G/DL, NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED. 17OCT2024 ADDITIONAL INFORMATION WAS PROVIDED FOR PATIENT PREVIOUSLY REPORTED ON (B)(6) 2024 SAMPLE ID (B)(6). ADDITIONAL RESULTS PROVIDED: WBC INITIAL RESULT = 10.4 10E3/UL, REPEAT RESULT = 13.6 10E3/UL, NEUTROPHIL INITIAL RESULT = 3.49, REPEAT RESULT = 4.13, PLATELET INITIAL RESULT = 78.6 10E3/UL, REPEAT RESULT = 129 10E3/UL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20255777 ↗
• MalfunctionSep 9, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER OBSERVED IMPRECISE HEMOGLOBIN RESULTS GENERATED ON THE CELL DYN RUBY ANALYZER FOR ONE PEDIATRIC SAMPLE. THE FOLLOWING DATA WAS PROVIDED: CBC RRBC MODE HEMOGLOBIN RESULT WAS 7.94; THE RESULT FROM THE PREVIOUS DAY WAS 11. REPEATED AGAIN AND THE RESULT WAS 11.5; USING THE GASOMETER THE RESULT WAS 6.7. THEY REPROCESS CBC + RRBC IN RUBY GIVING 6.75, CBC + NOC GIVES 6.8. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20171589 ↗
• MalfunctionAug 13, 2024Leak/Splash; Leak/Splash

  THE CUSTOMER OBSERVED THE WASTE CHAMBERS AND VENT CHAMBER WERE FULL ON THE CELL-DYN RUBY ANALYZER. THE CUSTOMER WENT TO PERFORM A CLEANING OF WASTE CHAMBER ON THE ANALYZER AND A TUBING CAME OFF CAUSING A SPRAY. THE SPRAY FROM THE TUBING WENT ONTO THE CEILING AND THEN DRIPPED FROM THE CEILING ONTO THE TOP OF THE CUSTOMER¿S HEAD. THE CUSTOMER WAS WEARING GOGGLES AND A LAB COAT. THE CUSTOMER WASHED HER HAIR AND HAD NO OTHER TREATMENT. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED. THERE WAS NO ADDITIONAL HARM TO THE CUSTOMER REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19972246 ↗
• MalfunctionJun 28, 2024Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED A FALSELY DEPRESSED PLATELET ON THE CELL-DYN RUBY FOR ONE PATIENT THAT WAS NOT REPORTED OUT OF THE LABORATORY. THE FOLLOWING RESULTS WERE PROVIDED: INITIAL PLATELET= 17.5 (10E3/UL); REPEAT PLATELET= 105 (10E3/UL) THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19632978 ↗
• MalfunctionMay 14, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER OBSERVED IMPRECISE HEMOGLOBIN RESULTS GENERATED ON THE CELL DYN RUBY ANALYZER. THE FOLLOWING DATA WAS PROVIDED (NORMAL RANGE 12 TO 14.5): SAMPLES FROM ONE PATIENT: APRIL 14 12.7. APRIL 14 8.7. APRIL 15 8.5. APRIL 16 8.6. APRIL 16 7.8. APRIL 17 9.1. APRIL 17 8.6. APRIL 17 9.1. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19310269 ↗
• MalfunctionApr 30, 2024High Test Results; High Test Results

  THE CUSTOMER OBSERVED ELEVATED HEMOGLOBIN (HGB) AND HEMATOCRIT (HCT) RESULTS FOR ONE PATIENT ON A CELL-DYN RUBY ANALYZER. THE FOLLOWING DATA WAS PROVIDED: SAMPLE ID (B)(4). INITIAL HGB RESULT WAS 23.6, REPEAT RESULTS WERE 15.1 AND 15.3 G/DL; INITIAL HCT RESULT WAS 71.4, REPEAT RESULTS WERE 46.9 AND 47.5%. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19212805 ↗
• MalfunctionMar 1, 2024Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DECREASED HEMOGLOBIN RESULTS GENERATED ON THE CELL-DYN RUBY ANALYZER FOR ONE HEMODIALYSIS PATIENT FROM MULTIPLE DRAWS. THE RESULTS PROVIDED WERE: ON (B)(6) 2024 INITIAL RESULT ON CLOSE MODE=6.8 G/DL, REPEATED SAME SPECIMEN AT ANOTHER LABORATORY ON (B)(6) 2024 (UNKNOWN PLATFORM) = 8.0 G/DL ON (B)(6) 2024 TWO SPECIMENS DRAWN FROM THE PATIENT VEIN AND CATHETER; VEIN R2V ON OPEN MODE=6.6 G/DL; CATHETER R2C ON OPEN MODE = 6.8 G/DL, REPEATED ON 09FEB2024 R2V=6.78 G/DL, SAMPLE REPEATED ON BLOOD BANK RUBY=7.17 G/DL ((B)(6)), SAME SPECIMEN PROCESS AT ANOTHER REFERENCE LABORATORY (UNKNOWN PLATFORM) =7.30 G/DL, AFTER TROUBLESHOOTING REPEATED = 6.67 G/DL ON (B)(6) 2024 NEW SPECIMEN REDRAWN AND REPEATED AT ANOTHER LAB (UNKNOWN PLATFORM) =8.0 G/DL THE CUSTOMER REPORTED THE RESULTS QUESTIONED BY THE DOCTOR, DUE TO THE LOW VALUE, HE ASKED THAT THE PATIENT BE TRANSFUSED; HOWEVER, PRIOR TO THE PROCEDURE, THE RESULT WAS CORROBORATED AND WAS HIGHER, THEREFORE THE TRANSFUSION WAS CANCELED. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18815536 ↗
• MalfunctionFeb 15, 2024Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DECREASED CBC RESULTS GENERATED ON THE CELL-DYN RUBY ANALYZER FOR PATIENT SAMPLES. THE FOLLOWING DATA WAS PROVIDED: PATIENT 2 PLATELET RESULT = 6.0, SLIDE REVIEW RESULT = 150 (NORMAL). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18715227 ↗
• InjuryFeb 13, 2024Unintended Movement; Unintended Movement

  THE ABBOTT FIELD SERVICE REPRESENTATIVE (FSR) WAS INJURED WHEN INSTALLING A CELL-DYN RUBY ANALYZER. THE FSR WAS ASSISTING THE MOVERS WITH PUTTING LIFTING HANDLES ON BOTH SIDES OF THE ANALYZER WHILE IT WAS SITTING ON A PALLET. THE FSR WAS SLIGHTLY LIFTING ONE SIDE OF THE ANALYZER SO THE MOVER COULD SLIDE THE ANALYZER OVER TO ONE SIDE OF THE PALLET, WHEN THE MOVER LIFTED THE ANALYZER, IT PUT ALL THE ANALYZER¿S WEIGHT ON THE FSR¿S ARM. THE FSR HEARD A POP AND FELT EXTREME PAIN SHOOT THROUGH THE LEFT ARM FROM BICEP MUSCLE DOWN THROUGH THE LEFT ARM. THE FSR WENT TO AN URGENT CARE FACILITY WHERE AN X-RAY FOUND NOTHING WAS BROKEN IN THE ARM, HOWEVER, THE FSR WENT TO AN ORTHOPEDIC DOCTOR THE NEXT MORNING WHERE AN ULTRASOUND CONCLUDED THAT THE TENDON FOR THE LEFT BICEP MUSCLE HAD TORN AWAY FROM THE MUSCLE AND NEEDED SURGERY TO REPAIR. THE SURGERY WAS SUCCESSFUL.

  Patient problems: Muscle/Tendon Damage

  MAUDE report 18699191 ↗
• InjuryFeb 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING THE DE-INSTALLATION PROCESS OF THE CELL DYN RUBY ANALYZER ON (B)(6) 2023, THE TECHNICAL SERVICE SPECIALIST (TSS) (49-YEAR-OLD MALE) WAS INJURED WHEN MOVING THE EQUIPMENT. THE TSS WAS CARRYING OUT THE PROCESS OF DEMOBILIZING DIAGNOSTIC EQUIPMENT CELL DYN RUBY (SERIAL (B)(6) AND AFTER UNINSTALLING THE EQUIPMENT, THE TSS WENT TO REMOVE THE EQUIPMENT FROM THE BENCH AND POSITION IT ON A CART FOR TRANSPORTATION. DUE TO THE WEIGHT (APPROXIMATELY 100KG), IT WAS NOT POSSIBLE TO MOVE ALONE, SO THE TSS REQUESTED HELP FROM A SERVICE PROVIDER FROM ANOTHER COMPANY THAT WORKS FOR THE CLIENT TO MOVE THE EQUIPMENT FROM THE BENCH (APPROXIMATELY 1.20M HIGH) TO A TRANSPORT CART (APPROXIMATELY 0.20M HIGH). WHEN THE TSS LIFTED THE EQUIPMENT, HE LOST STRENGTH IN HIS RIGHT ARM LETTING THE EQUIPMENT FALL TO THE FLOOR. AFTER A FEW MINUTES HE REGAINED STRENGTH AND FINISHED THE TASK. THE EQUIPMENT WAS TAKEN TO THE LOCATION FOR STORAGE AND SUBSEQUENT COLLECTION FROM THE CUSTOMER. HE FELT PAIN IN HIS RIGHT ARM, WHICH IMPROVED SPONTANEOUSLY. WHEN HE REMOVED HIS COAT, HE SAW THAT HIS BICEPS MUSCLE WAS RETRACTED AND DECIDED TO SEEK MEDICAL ATTENTION AT (B)(6) HOSPITAL WHERE HE WAS DIAGNOSED WITH A TENDON RU

  Patient problems: Muscle/Tendon Damage

  MAUDE report 18694715 ↗
• MalfunctionJan 26, 2024Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED A FALSELY DEPRESSED HEMOGLOBIN CELL-DYN RUBY RESULT WHEN COMPARED TO THE ALINITY HQ RESULT FOR ONE PATIENT. THE FOLLOWING DATA WAS PROVIDED: RUBY HEMOGLOBIN = 7.85 G/DL ALINITY HQ HEMOGLOBIN = 8.71 G/DL THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18588033 ↗
• MalfunctionJan 16, 2024Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DECREASED WBC AND PLATELET RESULTS GENERATED ON THE CELL DYN RUBY FOR MULTIPLE SAMPLES. THE INITIAL WBC RESULTS FOR THESE PARAMETERS WERE 0.00 OR CLOSE TO 0.00. THE DISCREPANT RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. THE FOLLOWING DATA WAS PROVIDED: (B)(6) 2023 SID (B)(6) PLATELET: INITIAL RESULT = 9.02 10E3/UL, REPEAT = 184 10E3/UL SID (B)(6) WBC: INITIAL RESULT = 0.023 10E3/UL, REPEATS = 10.5 10E3/UL. (B)(6) 2023 SID (B)(6) PLATELET: INITIAL RESULT = 0.00 10E3/UL, REPEAT = 297 10E3/UL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18522643 ↗
• MalfunctionJan 16, 2024Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DEPRESSED WBC AND PLATELET RESULTS GENERATED ON THE CELL DYN RUBY FOR MULTIPLE SAMPLES. THE INITIAL RESULTS FOR THESE PARAMETERS WERE 0.00 OR CLOSE TO 0.00. THE DISCREPANT RESULTS WERE NOT REPORTED OUT OF THE LABORATORY. THE FOLLOWING DATA WAS PROVIDED: (B)(6) 2023 SID (B)(6): PLATELET: INITIAL RESULT = 0.00 K/UL, REPEAT = 209 K/UL (B)(6) 2023 SID (B)(6): WBC: INITIAL RESULT = 0.001 K/UL, REPEAT = 2.04 K/UL (B)(6) 2023 SID (B)(6): WBC: INITIAL RESULT = 0.00 K/UL, REPEAT = 10.5 K/UL (B)(6) 2023 SID (B)(6): WBC: INITIAL RESULT = 0.001 K/UL, REPEATS = 6.30 K/UL AND 6.37 K/UL (B)(6) 2023 SID (B)(6): WBC: INITIAL RESULT = 0.001 K/UL, REPEAT = 6.13 K/UL (B)(6) 2023 SID (B)(6) : WBC: INITIAL RESULT = 0.00 K/UL, REPEAT = 11.3 K/UL PLATELET: INITIAL RESULT = 0.00 K/UL, REPEAT = 298 K/UL (B)(6) 2023 SID (B)(6) : PLATELET: INITIAL RESULT = 0.00 K/UL, REPEAT = 432 K/UL, 411 K/UL, AND 434 K/UL NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18516734 ↗