VITROS Chemistry Products K+ Slides & CL- Slides (2019-09-11)

Starting date:

September 11, 2019

Posting date:

October 3, 2019

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-71137

Last updated: 2019-10-03

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  Reason
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  Affected products

Affected Products

1. VITROS Chemistry Products K+ Slides
2. VITROS Chemistry Products Cl- Slides
3. VITROS Chemistry Products Cl- Slides

Reason

Ortho Clinical Diagnostics determined the potential for intermittent slide dispense issues with some VITROS Chemistry Products Slide cartridges of Cl- and K+. The dispense issues are due to the anti-backup platen failing to advance inside the cartridge. When this occurs, a condition code posts alerting the customer of the issue.

The anti-backup platen (ABP) is a plastic platform that supports the slide stack inside the cartridge and is pushed along with the slides to the top of the cartridge during the slide dispense cycle. Our investigation found that during the manufacturing of specific lots of VITROS Cl- and K+ Slides, some cartridges may have been sealed in a manner that restricts the movement of the ABP.

If the ABP is restricted within the cartridge body, a slide will not be properly positioned, and the system will generate a condition code. Condition codes that indicate a slide dispense issue are listed in the enclosed 'Resolving Slide Dispense Issues' document.

NOTE: Our investigation determined the issue is intermittent and isolated to specific lots of VITROS Cl- and K+ Slides.

Affected products