Eightcheck 3WP X-TRA Control (2013-05-13)

Starting date:

May 13, 2013

Posting date:

February 11, 2014

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-37869

• Reason
• Affected products

Recalled Products

Eightcheck 3WP X-TRA Control

Reason

Control product Eightcheck 3WP X-TRA lot 3120, had an error on the Poch-100I assay barcode sheet for mean platelet volume (MPV), level 3 (l3). The barcode sheet had an incorrect MPV target value of 14.2 (correct value: 10.6). However, the table of values on the assay sheet was correct with a value of 10.6 for MPV l3. All other assay values for lot 3120 were correct. The barcode discrepancy was reported to the technical assistance center which led to discovery of incorrrect bar code value for MPV- l3 assay target. Customer was preparing the Poch-100Ito use the new Eightcheck 3WP X-TRA lot 3120 and noticed the discrepancy. The SAI assay confimed the discrepancy and initiate corrective action.

Affected products