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
Affected Products
- VITROS Chemistry Products K+ Slides
- VITROS Chemistry Products Cl- Slides
- 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
A. VITROS Chemistry Products K+ Slides
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
815 7596
Companies
- Manufacturer
-
Ortho-Clinical Diagnostics Inc.
100 Indigo Creek Drive
Rochester
14626
New York
UNITED STATES
B. VITROS Chemistry Products Cl- Slides
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
844 5207
Companies
- Manufacturer
-
Ortho-Clinical Diagnostics Inc.
100 Indigo Creek Drive
Rochester
14626
New York
UNITED STATES
C. VITROS Chemistry Products Cl- Slides
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
684 4471
Companies
- Manufacturer
-
Ortho-Clinical Diagnostics Inc.
100 Indigo Creek Drive
Rochester
14626
New York
UNITED STATES