CELL-DYN 02H30-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00380740002688), received between Oct 10, 2017 and May 29, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Incorrect Or Inadequate Test Results” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 29, 2020Thermal Decomposition of Device; Smoking; Thermal Decomposition of Device; Smoking

  HOLD FOR JG 6/1/2020THE CUSTOMER OBSERVED SMOKE FROM THE BACK OF THE CELL-DYN 3700 CS ANALYZER NEAR THE FAN FILTER. THE INSTRUMENT WAS INSPECTED AND A CHARRED CONNECTOR WAS FOUND ON THE POWER SUPPLY MODULE AC BOARD. NO FIRE WAS OBSERVED. THERE WERE NO INJURIES AND NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 10102933 ↗
• MalfunctionOct 10, 2017Incorrect Or Inadequate Test Results; Incorrect Or Inadequate Test Results

  THE CUSTOMER OBSERVED DISCREPANT NEUTROPHIL PATIENT RESULTS WHILE USING THE CELL-DYN 3700 ANALYZER. THE FOLLOWING DATA WAS PROVIDED FOR THE PATIENT. SID (B)(6) INITIAL 0.00 (0.00%), REPEAT 8.46 (88.6%). NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6938093 ↗

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-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-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-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-2020-2011 · Mar 15, 2011 · Terminated
  CELL-DYN Sheer Valve Assembly Driver Abbott Diagnostics Division, Santa Clara, CA 05054
• 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