VITROS® Chemistry Products System - LAC Slides (Lactate)
Brand(s)
Last updated
Summary
Product
VITROS® Chemistry Products System - LAC Slides (Lactate)
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 catalog number |
|---|---|---|
| VITROS® Chemistry Products System - LAC Slides (Lactate) | More than 10 numbers, contact manufacturer. | 815 0112 |
| VITROS® Chemistry Products System - LAC Slides (Lactate) | More than 10 numbers, contact manufacturer. | 843 3880 |
Issue
QuidelOrtho investigated customer complaints related to the inability to successfully calibrate VITROS® LAC slides on VITROS® XT 3400 systems and VITROS® XT 7600 systems. To resolve this issue, QuidelOrtho has adjusted the assay parameter used by the reflectometer to process VITROS® LAC slides. This parameter adjustment will be implemented beginning in add DRV 6339 (and above). QuidelOrtho advises affected customers to load add DRV 6339 (or above) upon receipt.
Recall start date: August 5, 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-77908
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