Health product recall

Dimension Vista System - Gentamicin Assay, Dimension Clinical Chemistry System - Gentamicin, Dimension Xpand System - Genamicin (Gent) Assay, Dimension EXL System Gentamicin (Gent) Assay (2018-04-24)

Starting date:
April 24, 2018
Posting date:
May 25, 2018
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type III
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-66854

Affected products

  1. Dimension Vista System - Gentamicin Assay
  2. Dimension Clinical Chemistry System - Gentamicin
  3. Dimension Xpand System - Gentamicin (Gent) Assay
  4. Dimension EXL System - Gentamicin (Gent) Assay

Reason

Siemens Healthcare Diagnostics has confirmed Dimension Gentamicin (Gent) lot bb8159 may exhibit inaccuracy for Quality Control (QC) and patient samples at the low end of the analytical measurement range. Maximum negative bias of 100% and 48% were observed for patient samples at 0.9 ug/ml [1.94 umol/l] and 1.9 ug/ml [4.1 umol/l], respectively. Patient samples at 2.6 ug/ml [5.62 umol/l] did not show a bias. The bias is due to the calibration curve not showing separation between the level 1 and level 2 calibrators. Based on the investigation, lots 17135bc, 17150bf, 17159bd, 17178ac, 17269bd, and 17312bb may also exhibit a similar separation between level 1 and level 2 calibrators over time.

Affected products

A. Dimension Vista System - Gentamicin Assay

Lot or serial number

12269BD
17135BC
17150BF
17159BD
17178AC
17312BB

Model or catalog number

K4012

Companies
Manufacturer

Siemens Healthcare Diagnostics Inc.

500 GBC DRIVE, MAILSTOP 514, P.O. BOX 6101

Newark

19714

Delaware

UNITED STATES

B. Dimension Clinical Chemistry System - Gentamicin

Lot or serial number

BB8159
EB8115
FB8275

Model or catalog number

DF12

Companies
Manufacturer

Siemens Healthcare Diagnostics Inc.

500 GBC DRIVE, MAILSTOP 514, P.O. BOX 6101

Newark

19714

Delaware

UNITED STATES

C. Dimension Xpand System - Gentamicin (Gent) Assay

Lot or serial number

BB8159
EB8115
FB8275

Model or catalog number

DF12

Companies
Manufacturer

Siemens Healthcare Diagnostics Inc.

500 GBC DRIVE, MAILSTOP 514, P.O. BOX 6101

Newark

19714

Delaware

UNITED STATES

D. Dimension EXL System - Gentamicin (Gent) Assay

Lot or serial number

BB8159
EB8115
FB8275

Model or catalog number

DF12

Companies
Manufacturer

Siemens Healthcare Diagnostics Inc.

500 GBC DRIVE, MAILSTOP 514, P.O. BOX 6101

Newark

19714

Delaware

UNITED STATES