VITROS Chemistry Product System-Ca Slides (Calcium)
Brand(s)
Last updated
Summary
Product
VITROS Chemistry Product System-Ca Slides (Calcium)
Issue
Medical devices - Performance
What to do
Contact the manufacturer if you require additional information.
Audience
Healthcare
Affected products
| Affected products | Lot or serial number | Model or catalogue number |
|---|---|---|
| VITROS Chemistry Product System-Ca Slides (Calcium) | Gen 67 and above | 145 0261 |
Issue
Generations (Gens) 67 and above of VITROS CA slides may experience an increased occurrence of condition code th4-63j during calibration, on VITROS XT 3400 and VITROS XT 7600 systems. Condition code th4-63j is generated when the reflectometer detects image variations which exceed an assay parameter defined on the assay data disk (add). If condition code th4-63j is generated during calibration, the calibration may fail.
Recall start date: July 14, 2025
Additional information
Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Chemistry
Companies
| Ortho-Clinical Diagnostics Inc. |
| 100 Indigo Creek Drive, Rochester, New York, United States, 14626 |
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-77764
Get notified
Receive notifications for new and updated recalls and alerts by category.