Pneumococci Factor 7F Antisera (2018-11-19)

Starting date:

November 19, 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-68672

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  Reason
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  Affected products

Affected products

Pneumococci Factor 7F Antisera

Reason

Pneumococcus factor 7f antisera from SSI Diagnostica, cat# 16931 (SS), Lot # C7F17U1 (expiry 05/14/2021) and Lot # C7F17X1 (expiry 03/11/2022) is subject to a recall. It has been determined that these 2 lots show a weak reaction for positive samples, and it is difficult to distinguish between positive and negative reactions.

Affected products