Z-2335-2025Class II

VITROS Chemistry Products Ca Slides; Catalog Number: 145 0261

Name: Z-2335-2025 VITROS Chemistry Products Ca Slides; Catalog Number: 145 0261
Creator: Ortho-Clinical Diagnostics, Inc.
Published: 2025-07-09
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2025-07-09 / Open, Classified / root cause: software

FDA source

Ortho-Clinical Diagnostics, Inc. began a recall of VITROS Chemistry Products Ca Slides; Catalog Number: 145 0261 on 2025-07-09. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-2335-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-07-09
Posted: 2025-08-15
Recalling firm: Ortho-Clinical Diagnostics, Inc.
Product: VITROS Chemistry Products Ca Slides; Catalog Number: 145 0261;
Product code: CJY Azo Dye, Calcium
Reason for recall: 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 tag: software
FDA 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 in commerce: 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.
Product codes and lots: Catalog Number: 145 0261; UDI-DI: 10758750009114; Affected GENs: 67 and above;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2335-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2335-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-08-27	2025-08-15

Product code CJY

K072440Class IIVitros Chemistry Products: Ca Slides (Model: 145 0261), Calibrators Kit 1 (Model: 188 2208)Ortho-Clinical Diagnostics, Inc. / cleared 2007-09-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)