Innovance D-Dimer

Starting date:

January 20, 2017

Posting date:

February 9, 2017

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-62138

• Reason
• Affected products

Reason

An extrapolation in the Innovance D-Dimer OUS setting can lead to false negative (as well as to false positive) results on the Sysmex CS-Systems. The issue may only occur under the condition the following conditions:

1. The result is falsely flagged with an antigen excess error that triggers an automatic re-measurement in a 1/19 dilution.
2. The raw signal of the re-measurement is below the limit of blank (LOB) of the method. Under such conditions the low re-measurement raw value may be strongly affected by the signal noise of the optical system and can generate an erroneous low reading. The raw value will be corrected by the dilution factor and can be deduced from calibration curve in a false low range.

Affected products