Rapidec Carba NP

Starting date:

March 10, 2017

Posting date:

April 21, 2017

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-63058

• Reason
• Affected products

Reason

Confirmation of a screen printing error mentionned on the strips of the impacted lots. It is written that 5 microliters must be pipetted and transferred to the wells "d" and "e". This information is wrong, the right volume to transfer is 25 microliters as specified in the instruction for use (ref. 20584, version e). This screen printing error could lead to a wrong protocol and pipetting 5 microliters instead of 25 microliters. When following the wrong protocol, there is not issue for the Carbapenamase positive strains all correctly identified as positive, but there is a potential risk of false positive result for Carbapenamase negative strains.

Affected products