Recall Z-2133-2014— Siemens Healthcare Diagnostics, Inc.
Class III · Terminated
Class III FDA medical device recall by Siemens Healthcare Diagnostics, Inc., initiated 2014-05-27, terminated 2014-12-15. It names 3 FDA 510(k) clearances: K130276, K112999, K073604. Product: Dimension¿ Integrated Chemistry Systems intended to measure a variety of analytes in human body fluids.. Reason: 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..
- Recalling firm
- Siemens Healthcare Diagnostics, Inc.
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2014-05-27
- Terminated
- 2014-12-15
- Firm location
- Newark, DE, United States
510(k) clearances named in this recall
3 on FDA's record- K130276 — DIMENSION EXL WITH LM SYSTEM
- K112999 — DIMENSION CLINICAL CHEMISTRY SYSTEM
- K073604 — DIMENSION EXL WITH LM CLINICAL CHEMISTRY SYSTEM, DIMENSION FT4L FLEX REAGENT CARTRIDGE, AND LOCI THYROID CALIBRATOR, MOD
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Dimension¿ Integrated Chemistry Systems intended to measure a variety of analytes in human body fluids.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.