Elecsys Anti-CCP (2019-07-05)

Starting date:

July 5, 2019

Posting date:

July 26, 2019

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-70521

Last updated: 2019-07-26

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  Reason
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  Affected products

Affected Products

Elecsys Anti-CCP

Reason

Potential false high results may be obtained while using specific lots of Elecsys Anti-CCP on cobas e 411, cobas e 601, cobas e 602 and/or cobas e 801 instruments. This issue may only affect plasma samples and serum samples are not impacted.

Affected products