Dimension Chemistry System, Dimension Clinical Chemistry System, Dimension EXL System and Dimension XPAND System (2014-07-11)

Starting date:

July 11, 2014

Posting date:

August 1, 2014

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-40755

• Reason
• Affected products

Recalled Products

A) Dimension Chemistry System-RXL analyzer
B) Dimension Clinical Chemistry System-XL analyzer
C) Dimension Clinical Chemistry System –RXL analyzer
D) Dimension Chemistry System - XL analyzer
E) Dimension Clinical Chemistry System –RXL Max Analyzer
F) Dimension EXL System-Dimension EXL Analyzer (Licence #  78489)
G) Dimension EXL System-Dimension EXL Analyzer (Licence # 78489)
H) Dimension XPAND System-Dimension XPAND HM Analyzer
I) Dimension Clinical Chemistry System - RXL Max Analyzer (Licence # 2232)
J)  Dimension Clinical Chemistry System - RXL Max Analyzer (Licence # 7757)
K) Dimension EXL System-Dimension EXL Analyzer (Licence # 79670)
L) Dimension EXL System -Dimension EXL- LM Analyzer
M) Dimension EXL System -Dimension EXL 200 Analyzer
N)  Dimension XPAND System-Dimension XPAND HM
O) Dimension XPAND System - Dimension XPAND plus HM (Licence # 30615)
P) Dimension XPAND System - Dimension XPAND plus HM (Licence # 33405)

Reason

Siemens Healthcare Diagnostics has received complaints of QC and patient sample result accuracy shifts on CTNI (RF421C), LTNI (RF521C), FT4 (RF410), TSH (RF412), PBNP (RF423A) and LPBN (RF523A) when using dimension chemistry wash lot RD41041 on the dimension chemistry analyzers listed above. Internal investigation has confirmed bacterial contamination in chemistry wash lot RD41041.

Affected products