Advia Centaur Folate (FOL) Assay

Starting date:

November 7, 2012

Posting date:

December 10, 2012

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public (GP), Healthcare Professionals, Hospitals

Identification number:

RA-16259

• Reason
• Affected products

Products Recalled

1. Advia Centaur Folate (FOL) Assay
2. Advia Centaur Digitoxin (DGTN) Assay
3. Advia Centaur Folate (FOL) Assay
4. Advia Centaur Theophyllin 2 (THEO 2) Assay
5. Advia Centaur BR Assay
6. Advia Centaur CA 19-9 Assay
7. Advia Centaur B-Type Natriuretic Peptide (BNP) Assay
8. Advia Centaur B-Type Natriuretic Peptide (BNP) Assay
9. Advia Centaur BR Assay
10. Advia Centaur Digitoxin (DGTN) Assay
11. Advia Centaur Folate (FOL) Assay
12. Advia Centaur Theophylline 2 (THEO 2) Assay
13. Advia Centaur BR Assay
14. Advia Centaur Theophylline 2 (THEO 2) Assay
15. Advia Centaur CA 19-9 Assay
16. Advia Centaur CA 19-9 Assay
17. Advia Centaur B-Type Natriuretic Peptide (BNP) Assay
18. Advia Centaur DHEA-SO4 (DHEAS) Assay
19. Advia Centaur DHEA-SO4 (DHEAS) Assay
20. Advia Centaur DHEA-SO$ (DHEAS) Assay
21. Advia Centaur Digitoxin (DGTN) Assay
22. Advia Centaur Procalcitonin (PCT) Assay
23. Advia Centaur Procalcitonin (PCT) Assay
24. Advia Centaur Procalcitonin (PCT) AssayQ. Advia Centaur B-Type Natriuretic Peptide (BNP) Assay

Reason

The Advia Centaur Assays listed above, show changes in patient samples and quality control values when the ambient temperature of the room or laboratory shifts between 18° C - 30° C where the Advia Centaur system is installed. These assays are not meeting the specifications within the operating temperature range which is 18° C - 30° C. This effect occurs on either the Advia Centaur, Advia Centaur XP, and/or Advia Centaur CP systems depending on the assay and the system.

Affected products