VersaCell® X3 10793839Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00630414595177), received between Oct 9, 2020 and Mar 19, 2021 — classified as 3 malfunctions.

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

13 other recalls cover devices cleared under the same FDA submission (K970227); 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.

• MalfunctionMar 19, 2021Mechanical Problem; Mechanical Problem

  THE CUSTOMER INFORMED SIEMENS THAT THE VERSACELL X3 SYSTEM DROPPED SAMPLE TUBES. THE CUSTOMER REPORTED THAT SAMPLE TUBES WERE DROPPED INSIDE THE SYSTEM AND CONTAMINATED SAMPLES IN THE RACK. THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DROPPED SAMPLE TUBES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11529703 ↗
• MalfunctionMar 19, 2021Mechanical Problem; Mechanical Problem

  THE CUSTOMER INFORMED SIEMENS THAT THE VERSACELL X3 SYSTEM DROPPED SAMPLE TUBES. THE CUSTOMER REPORTED THAT SAMPLE TUBES WERE DROPPED INSIDE THE SYSTEM AND CONTAMINATED SAMPLES IN THE RACK. THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE DROPPED SAMPLE TUBES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11529702 ↗
• MalfunctionOct 9, 2020Electrical Power Problem; Electrical Power Problem

  THE CUSTOMER INFORMED SIEMENS THAT SMOKE EMITTED FROM INSIDE THE VERSACELL X3 SYSTEM. THE CUSTOMER DID NOT OBSERVE FLAMES FROM THE SYSTEM AND CONTACTED THE FIRE DEPARTMENT. THE CUSTOMER INFORMED THAT NO ONE FROM THE STAFF WAS INJURED OR HARMED DUE TO THE EVENT. THERE ARE NO KNOWN REPORTS OF ADVERSE HEALTH CONSEQUENCES DUE TO THE SMOKE EMITTED FROM THE VERSACELL X3 SYSTEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10657713 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K970227. One submission often covers many models, so check the product and lot details in each record.

• Z-2470-2020 · May 15, 2020 · Terminated
  Siemens IMMULITE 2000 XPi Immunoassay System - In vitro Chemistry Analyzer SMN #10373214 - Product Usage: are intended for professional use in a laboratory environment only.
• Z-2469-2020 · May 15, 2020 · Terminated
  Siemens IMMULITE 2000 Immunoassay System - In vitro Chemistry Analyzer SMN #10380062 - Product Usage: are intended for professional use in a laboratory environment only.
• Z-1662-2015 · Mar 5, 2015 · Terminated
  Water Feed Kit, Catalog#10288216,#10389714. The Immulite 2000 systems are continuous random-access instruments that perform chemiluminescent immunoassays. These instruments use se
• Z-1658-2015 · Mar 5, 2015 · Terminated
  Water bottles, Catalog#10380062, #10291586. The Immulite 2000 and 2000 XPi systems are continuous random-access instruments that perform chemiluminescent immunoassays. These instr
• Z-1663-2015 · Mar 5, 2015 · Terminated
  Liquid Waste Bottle Kit, Catalog#10386287. The Immulite 2000 and 2000 XPi systems are continuous random-access instruments that perform chemiluminescent immunoassays. These instru
• Z-1660-2015 · Mar 5, 2015 · Terminated
  Accessory Kit, Catalog#10282965, #10373217,#10286080. The Immulite 2000 systems are continuous random-access instruments that perform chemiluminescent immunoassays. These instrume
• Z-1661-2015 · Mar 5, 2015 · Terminated
  Direct Water feed Kit, Catalog#10373222
• Z-1832-2014 · Apr 25, 2014 · Terminated
  VersaCell X3 Solution and VersaCell X3 Expansion Pack, a robotic laboratory sample-management system. It connects up to 3 instruments and provides a user interface that routes sam
• Z-1316-2014 · Feb 3, 2014 · Terminated
  IMMULITE 2000; IMMULITE 2000XPi; VersaCell The IMMULITE 2000 systems are continuous random-access instruments that perform chemiluminescent immunoassays. These instruments use ser
• Z-1033-2010 · Oct 21, 2009 · Terminated
  IMMULITE 2000 and IMMULITE 2500 IgG/IgM Sample Diluent, Cat. No. L2IGZ2, Lot Number 150
• Z-1891-2010 · May 15, 2009 · Terminated
  IMMULITE 2000/2500 Chemiluminescent Substrate Module For the use in the routine operation of the IMMULITE 2000 and IMMULITE 2500 Analyzer.
• Z-1399-2009 · Jan 5, 2009 · Terminated
  Immulite 2000 and Immulite 2500 digital Fluidics PC Board, Part Number 450116-0002. Performs chemiluminescent immunoassays using serum, plasma, and/or urine for in vitro diagnosti
• Z-0994-05 · Apr 22, 2005 · Terminated
  IMMULITE 2000. An Automated, Quantitative Immunoassay Analyzer for In Vitro Diagnostic Use. Manufactured by DPC Cirrus Inc., Flanders, NJ 07836