Assayed Bovine Multi-Sera - Level 1 (2019-06-05)

Starting date:

June 5, 2019

Posting date:

June 21, 2019

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type III

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-70261

Last updated: 2019-06-21

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  Reason
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  Affected products

Affected Products

Assayed Bovine Multi-Sera - Level 1

Reason

Randox is re-assigning the Mean of all Instruments target and range for Bile Acids (5th Generation Colorimetric) in the Assayed Bovine Multi-Sera Level 1 Control Lot 205SL. Updated value sheets are now available on www.randox.com under Support and Documentation and attached to the email of this contact. No other lots or products are affected by this issue.

Affected products