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Health product recall

AB SCIEX LC/MS/MS SYSTEM (2016-06-16)

Starting date:
June 16, 2016
Posting date:
July 7, 2016
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
Healthcare Professionals, General Public, Hospitals
Identification number:
RA-59258

Affected products

A. API 3200MD LC/MS/MS SYSTEM

B.  3200MD QTRAP LC/MS/MS SYSTEM

C. TRIPLE QUAD 4500MD LC/MS/MS SYSTEM

D. QTRAP 4500MD LC/MS/MS SYSTEM

 

Reason

SCIEX is initiating a field action for the MultiQuant MD Software versions 3.0, 3.0.1 and 3.0.2.  MultiQuant MD software is for use with the API 3200MD LC/MS/MS system, 3200MD QTRAP LC/MS/MS system, triple quad 4500MD LC/MS/MS system and QTRAP LC/MS/MS system. An issue has been identified with MultiQuant MD software where under certain conditions a user can be presented with incorrect quantitative results when using the sum multiple ions feature.

Affected products

A. API 3200MD LC/MS/MS SYSTEM

Lot or serial number

BV20701511

Model or catalog number

5024501

Companies
Manufacturer
AB SCIEX PTE. LTD.,
04-06 MARSILING INDUSTRIAL ESTATE, ROAD 3, BLK 33
739256
SINGAPORE

B.  3200MD QTRAP LC/MS/MS SYSTEM

Lot or serial number

BU20201504

Model or catalog number

5024500

Companies
Manufacturer
AB SCIEX PTE. LTD.,
04-06 MARSILING INDUSTRIAL ESTATE, ROAD 3, BLK 33
739256
SINGAPORE

C. TRIPLE QUAD 4500MD LC/MS/MS SYSTEM

Lot or serial number

BX20951511

Model or catalog number

5031257

Companies
Manufacturer
AB SCIEX PTE. LTD.,
04-06 MARSILING INDUSTRIAL ESTATE, ROAD 3, BLK 33
739256
SINGAPORE

D. QTRAP 4500MD LC/MS/MS SYSTEM

Lot or serial number

BW20201508

Model or catalog number

5031231

Companies
Manufacturer
AB SCIEX PTE. LTD.,
04-06 MARSILING INDUSTRIAL ESTATE, ROAD 3, BLK 33
739256
SINGAPORE