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