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Health product recall

Vidas D-Dimer Exclusion II Ref 30455

Starting date:
December 21, 2012
Posting date:
January 21, 2013
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type I
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-16815

Recalled Products

  1. Vidas D-Dimer Exclusion II Ref 30455

Reason

Biomerieux has registered two complaints on false negative results under the detection limit (less than 45 ng/ml) using the batch 1001399220.

Affected products

A. Vidas D-Dimer Exclusion II Ref 30455

Lot or serial number

1001399220

Model or catalog number

30 455

Companies
Manufacturer
Biomerieux SA