Vitek Compact Systems (2017-04-20)

Starting date:

April 20, 2017

Posting date:

June 7, 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-63500

• Reason
• Affected products

Affected Products

1. Vitek 2 Compact 30 System - Susceptibility Test C
2. Vitek 2 Compact 60 System - Susceptibility Test C
3. Vitek 2 System - Susceptibility Test Cards
4. Vitek2  Yeast Identification Card (Yst)
5. Vitek  2 Gp Id
6. Vitek 2 Bcl Id
7. Vitek 2 Nh Id
8. Vitek 2 Anc Id
9. Vitek 2 Ast Gp69
10. Vitek 2 Ast Gn38
11. Vitek 2 Ast Gp71
12. Vitek 2 Ast P619
13. Vitek 2 Ast Gn48
14. Vitek 2 Ast Gn49
15. Vitek 2 Ast Gn65
16. Vitek 2 Ast N223
17. Vitek 2 Ast N233
18. Vitek 2 Ast Xn05
19. Vitek 2 Ast Gn66
20. Vitek 2 Ast Gn67
21. Vitek 2 Ast Gn69
22. Vitek 2 Ast Gn70
23. Vitek 2 Ast Gn71
24. Vitek 2 Ast Gn73
25. Vitek 2 Ast Gn84
26. Vitek 2 Ast Gn75
27. Vitek 2 Ast Gn77
28. Vitek 2 Ast Gn79
29. Vitek 2 Ast Gn80
30. Vitek 2 Ast Gn81
31. Vitek 2 Ast Gn82
32. Vitek 2 Ast Gn74
33. Vitek 2 Ast Gn86
34. Vitek 2 Ast Gn87
35. Vitek 2 Ast Xn06
36. Vitek 2 Ast N270
37. Vitek 2 Ast Gn90
38. Vitek 2 Ast Gn91
39. Vitek 2 Ast Gn92
40. Vitek 2 Ast N298
41. Vitek 2 Ast P635
42. Vitek 2 Ast Gp76
43. Vitek 2 Ast Ys08
44. Vitek 2 Ast St02
45. Vitek 2 Ast St03
46. Vitek 2 Gn Card

Reason

A Vitek 2 card pouch integrity issue has been identified for a portion of the card pouches manufactured with raw material white webbing.  Reports from customers have indicated occurrences of higher-than-expected minimum inhibitory concentration (MIC) results for imipenem and nitrofurantoin. Multiple card types/lots are referenced in the complaints. One of the customers determined, via parallel testing, that cards contained in white pouches showing visual evidence of a puncture or tear in the pouch at the stitch seal sometimes provided higher MIC values than pouches with no evidence of flaw.  An investigation was conducted to determine the root cause and scope of the pouch integrity issue. The investigation confirmed that a card pouch defect can allow humidity/moisture to impact the card. Moisture sensitivity can lead to antibiotic degradation (loss of potency). This could explain the increased antibiotic resistance experienced by some customers. The investigation determined the root cause was combinations of stitch seal wheel design/positioning on the manufacturing equipment, and product shipping/handling. The investigation concluded the card pouch integrity issue potentially impacts 204 card types (504 lots) worldwide.

Affected products