Various In Vitro Diagnostic Test Kits

Starting date:

January 31, 2013

Posting date:

June 18, 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-34237

• Reason
• Affected products

Recalled products

1. HBsAg Serum Cassette Rectangular Shape Single Pouched
2. HBsAg Serum Cassette Rectangular Shape M8 Single Pouched in Nandz HBSAG
3. HBsAg Serum 3.5mm Single Pouched
4. HBsAg Serum Strip 3mm S.P.
5. HBsAg S/WB Strip 3.5mm S.P.
6. Anti-HBS Serum Cassette Rectangular Shape Single Pouched
7. Hepatitis B Multi-Panel Test
8. Anti-HCV Serum Strip 3.5mm Single Pouched
9. Anti-HCV Serum Cassette Rectangular Shape Single Pouched
10. Anti-HCV Serum M5 Cassette Rectangular Shape Single Pouched Nanz Pouch
11. Anti-HCV Serum M8 Cassette Rectangular Shape Single Pouched
12. Anti-HCV Cassette Rectangular Shape Single Pouched Ind Infec Pouch
13. Syphilis Strip 3.5mm Single Pouched
14. Syphilis Serum Strip 2.5mm S.P.
15. Syphilis Cassette Rectangular Shape Single Pouched
16. PSA Serum Strip 5mm Single Pouched
17. Anti-HIV 1+2 Serum M9 Cass Rect Single Pouched Solution in Bottle in Nanz HIV Pouch
18. Anti-HIV 1+2 Serum Cass Rect Single Pouched Solution in Bottle Ind Infec Pouch with 50t/box
19. Anti-HIV 1+2 Serum Cass Rect Single Pouched Solution in Bottle in Nanz HIV Pouch
20. Anti-HIV 1+2 Serum 3line M9 Cassette S.P. (Solution in 25 t/bottle) in Nanz HIV Pouch
21. HIV (1+2) Whole Blood/serum Cassette S.P. 25t/kit
22. H-Pylori Cassette S.P.

Reason

Export only products lacked S.37 certificates.

Affected products