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Health product recall

Beckman Coulter Immunochemistry System Assays (2016-04-11)

Starting date:
April 11, 2016
Posting date:
April 19, 2016
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type I
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-57972

Affected Products

A. Cholesterol OSR6x16

B. Cholesterol OSR6x16

C. Lactate OSR6x93

D. Lactate OSR6x93

E. Triglyceride OSR6x118

F. Uric Acid OSR6x98

G. Triglyceride OSR6x118

H. Uric Acid OSR6x98

I. Cholesterol OSR6x16

J. Lipase OSR6x30

K. Lactate OSR6x93

L. Triglyceride OSR6x118

M. Uric Acid OSR6x98

N. Lipase OSR6x30

O. Lipase OSR6x30

P. Enzymatic Creatinine OSR6x204

Reason

Beckman Coulter has identified that there is a possibility that drug interferences from administration of metamizole (dipyrone) to patients may generate false low results with the assays which are the subject of this recall. The issue was discovered on 23rd Feb 2016 internally by Beckman Coulter.

Affected products

A. Cholesterol OSR6x16

Lot or serial number

All lots.

Model or catalog number

OSR6116

OSR6216

OSR6516

OSR6616

Companies
Manufacturer

Beckman Coulter, Inc.

250 S. Kraemer Blvd.

Brea

92821

California

UNITED STATES



B. Cholesterol OSR6x16

Lot or serial number

All lots.

Model or catalog number

OSR6116

OSR6216

OSR6516

OSR6616

Companies
Manufacturer

Beckman Coulter, Inc.

250 S. Kraemer Blvd.

Brea

92821

California

UNITED STATES



C. Lactate OSR6x93

Lot or serial number

All lots.

Model or catalog number

OSR6193

Companies
Manufacturer

Beckman Coulter, Inc.

250 S. Kraemer Blvd.

Brea

92821

California

UNITED STATES



D. Lactate OSR6x93

Lot or serial number

All lots.

Model or catalog number

OSR6193

Companies
Manufacturer

Beckman Coulter, Inc.

250 S. Kraemer Blvd.

Brea

92821

California

UNITED STATES



E. Triglyceride OSR6x118

Lot or serial number

All lots.

Model or catalog number

OSR60118

OSR61118

OSR66118

Companies
Manufacturer

Beckman Coulter, Inc.

250 S. Kraemer Blvd.

Brea

92821

California

UNITED STATES



F. Uric Acid OSR6x98

Lot or serial number

All lots.

Model or catalog number

OSR6098

OSR6198

OSR6298

Companies
Manufacturer

Beckman Coulter, Inc.

250 S. Kraemer Blvd.

Brea

92821

California

UNITED STATES



G. Triglyceride OSR6x118

Lot or serial number

All lots.

Model or catalog number

OSR60118

OSR61118

OSR66118

Companies
Manufacturer

Beckman Coulter, Inc.

250 S. Kraemer Blvd.

Brea

92821

California

UNITED STATES



H. Uric Acid OSR6x98

Lot or serial number

All lots.

Model or catalog number

OSR6098

OSR6198

OSR6298

Companies
Manufacturer

Beckman Coulter, Inc.

250 S. Kraemer Blvd.

Brea

92821

California

UNITED STATES



I. Cholesterol OSR6x16

Lot or serial number

All lots.

Model or catalog number

OSR6116

OSR6216

OSR6516

OSR6616

Companies
Manufacturer

Beckman Coulter, Inc.

250 S. Kraemer Blvd.

Brea

92821

California

UNITED STATES



J. Lipase OSR6x30

Lot or serial number

All lots.

Model or catalog number

OSR6130

OSR6230

Companies
Manufacturer

Beckman Coulter, Inc.

250 S. Kraemer Blvd.

Brea

92821

California

UNITED STATES



K. Lactate OSR6x93

Lot or serial number

All lots.

Model or catalog number

OSR6193

Companies
Manufacturer

Beckman Coulter, Inc.

250 S. Kraemer Blvd.

Brea

92821

California

UNITED STATES



L. Triglyceride OSR6x118

Lot or serial number

All lots.

Model or catalog number

OSR60118

OSR61118

OSR66118

Companies
Manufacturer

Beckman Coulter, Inc.

250 S. Kraemer Blvd.

Brea

92821

California

UNITED STATES



M. Uric Acid OSR6x98

Lot or serial number

All lots.

Model or catalog number

OSR6098

OSR6198

OSR6298

Companies
Manufacturer

Beckman Coulter, Inc.

250 S. Kraemer Blvd.

Brea

92821

California

UNITED STATES



N. Lipase OSR6x30

Lot or serial number

All lots.

Model or catalog number

OSR6130

OSR6230

Companies
Manufacturer

Beckman Coulter, Inc.

250 S. Kraemer Blvd.

Brea

92821

California

UNITED STATES



O. Lipase OSR6x30

Lot or serial number

All lots.

Model or catalog number

OSR6130

OSR6230

Companies
Manufacturer

Beckman Coulter, Inc.

250 S. Kraemer Blvd.

Brea

92821

California

UNITED STATES



P. Enzymatic Creatinine OSR6x204

Lot or serial number

All lots.

Model or catalog number

OSR61204

Companies
Manufacturer

Beckman Coulter, Inc.

250 S. Kraemer Blvd.

Brea

92821

California

UNITED STATES


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