Ortho-Clinical Diagnostics, Inc.: VITROS Chemistry Products Ca Slides; Catalog Number: 145 0261;

Recall number

Z-2335-2025

Recalling firm

Ortho-Clinical Diagnostics, Inc.

Product

VITROS Chemistry Products Ca Slides; Catalog Number: 145 0261;

Status

Open, Classified

Initiated

2025-07-09

Posted

2025-08-15

Terminated

not on file

Reason

Generations 67 and above of VITROS Ca Slides are experiencing an increased occurrence of Condition Code TH4-63J during calibration on VITROS XT 3400 and VITROS XT 7600 Systems, causing calibration failures that delay calcium test results and potentially impact patient management. The imaging reflectometer algorithm detects excessive "spikes" (imperfections) in slide images and generates the TH4-63J condition code when the threshold of 600 spikes is exceeded. Updated analysis revealed a 19-fold increase in failure rates from 0.0043% (2024 baseline) to 0.082% for Generation 67+ slides in 2025, with 100% of calibrator failures occurring at the lowest concentration level. This can result in delayed diagnosis and treatment of conditions such as hypercalcemic crisis, parathyroid disorders, and other calcium-related emergencies requiring urgent intervention.

Root cause

Under Investigation by firm

Action

On July 9, 2025 URGENT PRODUCT CORRECTION NOTIFICATION letters were sent to customers. REQUIRED ACTIONS " Upon receipt, load ADD DRV 6338 on your VITROS XT 3400 and/or VITROS XT 7600 System(s). " Complete the enclosed Confirmation of Receipt form no later than July 17, 2025. " Save this notification with your User Documentation or post this notification by each VITROS XT 3400/VITROS XT 7600 System in your laboratory until the issue has been resolved. " Please forward this notification if the affected product was distributed outside of your facility. " If your laboratory has experienced the issue with this product and you have not already done so, please report the occurrence to your local Global Services Organization. Resolution The issue resolves upon loading ADD DRV 6338 however, QuidelOrtho s investigation to determine root cause is still in progress. We apologize for the inconvenience this issue may have caused your laboratory. If you have further questions, please contact our Global Services Organization at 1-800-421-3311. To report adverse events, contact your local Global Services Organization. Adverse reactions or quality problems experienced with the use of this product may also be reported to the FDA s MedWatch Adverse Event Reporting program: www.fda.gov/medwatch/report.htm, 1-800-332-1088. *****Update 8/4/2025***** On July 29, 2025 URGENT PRODUCT CORRECTION NOTIFICATION letters were sent to customers of additional products identified for this event. REQUIRED ACTIONS " Upon receipt, load ADD DRV 6339 (or above) on your VITROS XT 3400 and/or VITROS XT 7600 System(s). " Complete the enclosed Confirmation of Receipt form no later than August 6, 2025. " Save this notification with your User Documentation or post this notification by each VITROS XT 3400/VITROS XT 7600 System in your laboratory until the issue has been resolved. " Please forward this notification if the affected product was distributed outside of your facility. " If your laboratory has ex

Quantity

174,215 units

Distribution

Worldwide distribution - US Nationwide and the countries of Australia, Belgium, Bermuda, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Netherlands, Norway, Portugal, Russia, Singapore, Spain, Sweden, United Kingdom.

Lot, serial or model codes

Catalog Number: 145 0261; UDI-DI: 10758750009114; Affected GENs: 67 and above;

510(k) numbers

["K072440"]

PMA numbers

not on file

Product code

CJY

Firm FEI

1000136573

Firm city

Rochester

Firm state

NY

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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