Alinity i B12 Reagent Kit (2018-11-25)

Starting date:

November 25, 2018

Posting date:

January 8, 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-68676

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  Reason
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  Affected products

Affected products

Alinity i B12 Reagent Kit

Reason

Abbott has become aware of a manufacturing issue that can result in damage to a bottle neck in some of the reagent cartridges found in the lots listed in Appendix A. If a bottle neck is damaged, it may cause a failure during the reagent loading process on the Alinity i instrument.

Affected products