CELL-DYN 02H31-03Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00380740002732), received between Mar 13, 2018 and Apr 17, 2019 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Smoking” (2 reports).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 17, 2019Low Test Results; Low Test Results

  THE CUSTOMER REPORTED A FALSELY DECREASED HEMATOCRIT (HCT) RESULT ON ONE PATIENT. THE RESULTS PROVIDED WERE: (B)(6) 2019 = 23.6 / 24.5. THE CUSTOMER STATED THAT THE PATIENT WAS TRANSFUSED AS POLICY IS TO TRANSFUSE PATIENTS WITH HCTS <28. THE SAMPLE WAS REPEATED IN THE AFTERNOON AND THE HCT RESULTS WERE 30.2 / 34.3. THERE WAS NO ADVERSE IMPACT TO THE PATIENT REPORTED DUE TO THE UNNECESSARY TRANSFUSION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8523435 ↗
• MalfunctionFeb 22, 2019Smoking; Smoking

  THE CUSTOMER REPORTED THAT AFTER SYSTEM ACTIVATION, SMOKE WAS OBSERVED FROM THE CELL-DYN 3700 SL ANALYZER. THERE WAS NO REPORT OF INJURY OR ADVERSE IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8362894 ↗
• MalfunctionMar 13, 2018Smoking; Smoking

  THE CUSTOMER OBSERVED VISIBLE SMOKE AND EXPERIENCED AN ELECTRICAL FAILURE OF THE CELL-DYN 3700SL ANALYZER. THE CUSTOMER DISCONNECTED THE EQUIPMENT FROM THE ELECTRICAL CURRENT AND NO EXTERIOR DAMAGE WAS OBSERVED. NO INJURIES OR FIRE WERE REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 7336246 ↗

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-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-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-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-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-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-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