Health product recall

ADVIA Hematology System (2021-03-12)

Starting date:
March 12, 2021
Posting date:
April 1, 2021
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-75281



Last updated:
2021-04-01

Affected Products 

  1. ADVIA 2120 WITH DUAL ASPIRATION AUTOSAMPLER
  2. ADVIA 2120 WITH AUTOSAMPLER
  3. ADVIA 2120I ANALYZER WITH AUTOSAMPLER
  4. ADVIA 2120i Analyser with Autosampler

Reason

Siemens Healthcare Diagnostics Inc. has investigated a complaint and confirmed a potential that the ADVIA 2120/2120i Hematology System Software Versions 6.10 and 6.11 May misread patient sample 14-character Sample Identification (SID) barcodes which contain a non-alphanumeric character. This correction only applies to ADVIA 2120/2120i Hematology Systems running Software Version 6.10 or 6.11 and customers that have disabled the Barcode Encode Selectivity feature.

Affected products

A. ADVIA 2120 WITH DUAL ASPIRATION AUTOSAMPLER

Lot or serial number
  • IR09290607
  • IR15760724
  • IR08740603
Model or catalog number
  • 10313419
Companies
Manufacturer

Siemens Healthcare Diagnostics Inc.

511 Benedict Ave

Tarrytown

10591

UNITED STATES


B. ADVIA 2120 WITH AUTOSAMPLER

Lot or serial number
  • IR11720631
  • IR13120642
Model or catalog number
  • 10316162
Companies
Manufacturer

Siemens Healthcare Diagnostics Inc.

511 Benedict Ave

Tarrytown

10591

UNITED STATES


C. ADVIA 2120I ANALYZER WITH AUTOSAMPLER

Lot or serial number
  • More than 10 numbers, contact manufacturer. 
Model or catalog number
  • 10285573
  • 11219529
Companies
Manufacturer

Siemens Healthcare Diagnostics Inc.

511 Benedict Ave

Tarrytown

10591

UNITED STATES


D. ADVIA 2120i Analyser with Autosampler

Lot or serial number
  • More than 10 numbers, contact manufacturer. 
Model or catalog number
  • 10285572
  • 11219531
Companies
Manufacturer

Siemens Healthcare Diagnostics Inc.

511 Benedict Ave

Tarrytown

10591

UNITED STATES


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