CELL-DYN 02H31-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00380740002725), received between Oct 25, 2016 and Aug 21, 2018 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Display Difficult to Read” (1 report).

9 other recalls cover devices cleared under the same FDA submission (K991605); they may or may not involve this specific model.

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

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

• MalfunctionAug 21, 2018Thermal Decomposition of Device; Thermal Decomposition of Device

  THE CUSTOMER OBSERVED SMOKE COMING FROM THE BACK OF THE CELL-DYN 3700 ANALYZER. THE INSTRUMENT WAS TURNED OFF. NO INJURY OR EXPOSURE WAS REPORTED. THE FIELD SERVICE ENGINEER FOUND EVIDENCE OF FIRE ON THE PRESSURE PUMP PCB RELAY CARD.

  Patient problems: No Patient Involvement

  MAUDE report 7802605 ↗
• MalfunctionJan 25, 2018Fire; Fire

  THE CUSTOMER REPORTED A FIRE OCCURRED INSIDE THE CELL-DYN 3700 SL ANALYZER. SMOKE WAS OBSERVED COMING FROM THE ANALYZER WHEN THE MODE WAS CHANGED FROM CLOSED TO OPEN. THE CUSTOMER DISCONNECTED THE POWER CABLE OF THE ANALYZER FROM THE WALL OUTLET AND LEFT THE LABORATORY UNTIL THE SMOKE DISSIPATED. THE CUSTOMER FURTHER INDICATED THE FIRE DAMAGED MULTIPLE COMPONENTS AND WAS CONTAINED WITHIN THE ANALYZER WITH NO DAMAGE OUTSIDE THE ANALYZER. THERE WERE NO INJURIES AND NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 7219332 ↗
• MalfunctionOct 12, 2017Display Difficult to Read; Display Difficult to Read

  THE CUSTOMER REPORTED SAMPLE IDENTIFICATION MISMATCH ON THE CELL DYN 3700. (B)(6) WAS READ AS (B)(6) BY THE ANALYZER. PER THE LOG, IT APPEARS THAT (B)(6) WAS RUN TWO TIMES. THE INITIAL (B)(6) RUN GENERATED RESULTS WHICH MATCH WITH THE REPEAT RUN OF (B)(6). THE INITIAL RESULTS WERE REPORTED TO THE PHYSICIAN BUT NO TREATMENT WAS GIVEN BASED ON THOSE RESULTS. THE SECOND RUN OF (B)(6) WAS MORE IN LINE WITH THAT PATIENT'S HISTORICAL RESULTS. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT. THERE WAS NO ADDITIONAL PATIENT INFORMATION PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6945258 ↗
• MalfunctionOct 25, 2016High Test Results; High Test Results

  THE CUSTOMER STATED THAT THE CD3700 ANALYZER GENERATED A FALSELY ELEVATED PLATELET RESULT ON ONE PATIENT IN THE CLOSED MODE. THE INITIAL RESULT WAS 950 K/UL. THE CUSTOMER PERFORMED A MANUAL SMEAR AND OBSERVED NO PLATELETS, SO THEY RERAN THE SAMPLE AND THE RESULT WAS 300 K/UL. THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT. THERE WAS NO ADDITIONAL PATIENT INFORMATION PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6055196 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K991605. One submission often covers many models, so check the product and lot details in each record.

• Z-2020-2011 · Mar 15, 2011 · Terminated
  CELL-DYN Sheer Valve Assembly Driver Abbott Diagnostics Division, Santa Clara, CA 05054
• Z-2014-2011 · Mar 15, 2011 · Terminated
  CELL-DYN Shear Valve Assembly used on CELL-DYN 3700CS Analyzer and CELL-DYN 3700CS Analyzer (refurb). Abbott Diagnostics Division, Santa Clara, CA 05054 Designed for in vitro dia
• Z-2015-2011 · Mar 15, 2011 · Terminated
  CELL-DYN Shear Valve Assembly used on CELL-DYN 3700SL Analyzer and CELL-DYN 3700SL Analyzer (refurb). Abbott Diagnostics Division, Santa Clara, CA 05054 Designed for in vitro dia
• Z-2016-2011 · Mar 15, 2011 · Terminated
  CELL-DYN Shear Valve Assembly used on CELL-DYN 3500SL Analyzer and CELL-DYN 3500SL Analyzer (refurb). Abbott Diagnostics Division, Santa Clara, CA 05054 Designed for in vitro dia
• Z-2351-2010 · Apr 16, 2010 · Terminated
  CELL-DYN 3700 CS and SL, Hematology Analyzer manufactured by Abbott Laboratories, Santa Clara, CA. Waste Reservoir Assembly Part number 8921174802.
• Z-1701-2011 · Mar 27, 2009 · Terminated
  Abbott CELL-DYN 3700 Hematology Analyzer CS (Closed Sampler), , and CELL-DYN 3700 SL (Sample Loader), Manufactured by Abbott Diagnostics Division, Santa Clara, Ca Medical Device,
• Z-1703-2011 · Mar 27, 2009 · Terminated
  Abbott CELL-DYN 3500 Hematology Analyzer CS (Closed Sampler), CELL-DYN 3500 SL (Sample Loader). Manufactured by Abbott Diagnostics Division, Santa Clara, Ca Medical Device, hemato
• Z-1200-2007 · May 11, 2007 · Terminated
  Abbott CELL-DYN 3700 Hematology Analyzer
• Z-1199-2007 · May 11, 2007 · Terminated
  Abbott CELL-DYN 3500 Hematology Analyzer