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Cobas Integra C-Reactive Protein (Latex)(CRPL2) application for C.F.A.S., Cobas Integra C-Reactive Protein (Latex) High Sensitive (CRPHS), 24K Irrigation System - Remote Control, Cobas C-111 C-Reactive Protein (High Sensitive Assay), C-Reactive Protein Gen.3 (CRPL3), Hitachi Tina-Quant C-Reactive Protein(Latex) High Sensitive Assay (CRP), CRPL3 (C-Reactive Protein Gen. 3) for Cobas C701 Analyzer and CRPHS (Cardiac C-Reactive Protein (Latex) High Sensitive) (April 02, 2012)

Report a Concern
Starting date:
April 02, 2012
Posting date:
May 14, 2012
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Product Safety
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-73277

Reason

Significantly decreased CRP Values may be obtained from samples taken from patients who have been treated with carboxypenicillins.

Affected products

Cobas Integra C-Reactive Protein (Latex)(CRPL2) application for C.F.A.S.

Lot or serial number

All lots

Model or catalog number

20764930322

Companies

Manufacturer
Not Applicable



Cobas Integra C-Reactive Protein (Latex) High Sensitive (CRPHS)

Lot or serial number

All lots

Model or catalog number

04628918190

Companies

Manufacturer
Not Applicable



24K Irrigation System - Remote Control

Lot or serial number

All lots

Model or catalog number

05401615190

Companies

Manufacturer
Not Applicable



Cobas C-111 C-Reactive Protein (High Sensitive Assay)

Lot or serial number

All lots

Model or catalog number

05401607190

Companies

Manufacturer
Not Applicable



C-Reactive Protein Gen.3 (CRPL3)

Lot or serial number

All lots

Model or catalog number

04956842190, 04956885190, 04956923190, 04995554190

Companies

Manufacturer
Not Applicable



Hitachi Tina-Quant C-Reactive Protein(Latex) High Sensitive Assay (CRP)

Lot or serial number

All lots

Model or catalog number

11972855216

Companies

Manufacturer
Not Applicable



CRPL3 (C-Reactive Protein Gen. 3) for Cobas C701 Analyzer

Lot or serial number

All lots

Model or catalog number

05172373190

Companies

Manufacturer
Not Applicable



CRPHS (Cardiac C-Reactive Protein (Latex) High Sensitive)

Lot or serial number

All lots

Model or catalog number

05950864190

Companies

Manufacturer
Not Applicable