Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

Dimension Integrated Chemistry Systems intended to measure a variety of analytes in human body fluids.

FDA Recall Z-2133-2014 · Posted 2014-07-30

Recalling FirmSiemens Healthcare Diagnostics, Inc.
Recall StatusTerminated
Product CodeJJE
Date Initiated2014-05-27
Date Terminated2014-12-15
Product Quantity15

Reason for Recall

There is a misassembly issue with the photometer installed on Dimension Integrated Chemistry Systems instruments. Through internal investigation by Siemens Healthcare Diagnostics has confirmed that a limited number of Dimension photometers were misassembled. These photometers are performing within specifications, but may lead to a shortened life of the source lamp.

Firm Action

An urgent field safety notice, dated May 2014, was sent to users to inform them of the issue and that a service representative would replace the misassembled photometer.

Root Cause

Employee error

Distribution Pattern

FL LA AR IA OH OH WI IL LA KS MT

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K130276DIMENSION EXL WITH LM SYSTEMSiemens Healthcare Diagnostics, Inc. · 2013-03-22K112999DIMENSION CLINICAL CHEMISTRY SYSTEMSiemens Healthcare Diagnostics · 2011-11-22K073604DIMENSION EXL WITH LM CLINICAL CHEMISTRY SYSTEM, DIMENSION FT4L FLEX REAGENT CARTRIDGE, AND LOCI THYROID CALIBRATOR, MODDade Behring, Inc. · 2008-03-13

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑