Lower risk Medical device recall · FDA · Published July 29, 2025

Ortho-Clinical VITROS LAC Slides Recall: Calibration Failures Risk Patient Management

Ortho-Clinical recalls VITROS LAC Slides with coating 0130+ due to increased calibration failures causing delayed lab results and potential patient management impacts. Affected units include specific lot numbers and expiration dates.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-2560-2025Medical device Ortho-Clinical ›

Lower-risk recall

VITROS Chemistry Products LAC Slides on VITROS XT 3400 and VITROS XT 7600 Systems are experiencing an increased occurrence of calibration failure related to lots from coating 0130 and above with Condition Code TH4-63J during calibration, causing the delay of lac test results and potentially impact patient management. The issue was identified by QuidelOrtho through an increase in customer complaints compared to the historical baseline with average failure rate of 1% for coating 0130 in 2025 while average of failure rate for other coating was 0.06% in 2025 and average of failure rate for all coatings is 0.03% for 2024.

Take action

Contact the company

Recalling firmOrtho-Clinical Diagnostics, Inc.100 Indigo Creek Dr · Rochester, NY 14626-5101

✎ GovInfoNow plain-language explainer

Ortho-Clinical is recalling VITROS Chemistry Products LAC Slides that may cause calibration failures on certain lab systems, delaying lab results and potentially affecting patient care. This issue affects specific coating lots and expiration dates. Read more at govinfonow.com/recall/51721-ortho-clinical-vitros-lac-slides-recall-calibration-failures-risk-patient.

Source Summary by GovInfoNow · govinfonow.com/recall/51721-ortho-clinical-vitros-lac-slides-recall-calibration-failures-risk-patient · Updated August 17, 2026 · FDA enforcement record: FDA #Z-2560-2025

Cite this page

“Ortho-Clinical VITROS LAC Slides Recall: Calibration Failures Risk Patient Management.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/51721-ortho-clinical-vitros-lac-slides-recall-calibration-failures-risk-patient. Based on FDA recall #Z-2560-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2560-2025%22&limit=1).

The FDA announced on July 29, 2025, that Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products LAC Slides due to calibration failures that may delay test results. The agency issued the recall for catalog number 8150112 units distributed nationwide.

How to tell if you have it

Brand: Ortho-Clinical
Product: VITROS Chemistry Products LAC Slides
Catalog Number: 8150112
Lot numbers: 3533-0130-2947, 3533-0130-2972, 3533-0130-3001, 3533-0130-3002, 3533-0130-3048, 3533-0130-3084, 3533-0131-5887, 3533-0131-5958, 3533-0131-5962, 3533-0131-6058
Expiration date range: 01-Oct-2026 to 01-Jan-2027
Distribution: US Nationwide

The hazard

According to the FDA, VITROS Chemistry Products LAC Slides on VITROS XT 3400 and VITROS XT 7600 Systems are experiencing an increased occurrence of calibration failure related to lots from coating 0130 and above with Condition Code TH4-63J. This issue causes the delay of lac test results and potentially impacts patient management.

Context

GovInfoNow's records show Ortho-Clinical Diagnostics, Inc. has 53 other recalls on record since 2017-07-10. Recent similar recalls include Ortho-Clinical VITROS Ca Slides Recall (2025-07-09), Ortho-Clinical VITROS OP Reagent Gen 15 May Cause Inaccurate Test Results (2025-06-12), and Ortho-Clinical VITROS CHE Slides Recall: QC Drift Risk (2025-06-10). Other recent recalls of similar products include Medline Surgical Packs Recall: Calibration Issues May Affect Sterility (2026-01-07), Medline Convenience Kits Recall: Sterility Risk from Calibration Issues (2026-01-07), and Medline Surgical Packs Recall: Calibration Issues May Impact Sterility (2026-01-07).

How to tell if you have this one

Check for catalog number 8150112 on the slides. Affected units include coating 0130 and above with specific lot numbers listed in the recall (e.g., 3533-0130-2947) and expiration dates from October 2026 to January 2027.

Brand
Ortho-Clinical
Category
Medical device

FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Ongoing
Distribution
US Nationwide distribution.

Recall number	Product, codes & lots	Quantity
Z-2559-2025	Chemistry Products LAC Slides. Catalog Number: 8433880. 1 Sales Unit = contains 5 cartridges of 60 slides, for a total of 300 tests.; Catalog number 8433880; UDI# 110758750004911; Coating 0130 and above, this includes Lot numbers 3533-0130-2317, 3533-0130-2717, 3533-0130-2718, 3533-0130-2719, 3533-0130-4546, 3533-0130-4605, 3533-0131-4763, 3533-0131-6114, 3533-0131-6115, 3533-0131-6116, 3533-0131-6128; Expiration date range 01-Sep-2026 to 01-Jan-2027	2,908 units
Z-2560-2025	VITROS Chemistry Products LAC Slides. Catalog Number: 8150112. 1 Sales Unit = contains 5 cartridges of 18 slides, for a total of 90 tests.; Catalog number 8150112; UDI# 10758750004454; Coating 0130 and above, this includes Lot numbers 3533-0130-2947, 3533-0130-2972, 3533-0130-3001, 3533-0130-3002, 3533-0130-3048, 3533-0130-3084, 3533-0131-5887, 3533-0131-5958, 3533-0131-5962, 3533-0131-6058 ; Expiration date range 01-Oct-2026 to 01-Jan-2027	2,320 units

Based on the official FDA remedy

What to do — step by step

Check Product Details
Look for catalog number 8150112 and coating lots 0130+ on the slides.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “US Nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 57 days after the firm started it.

Jul 29, 2025Firm started the recall
Sep 12, 2025FDA classified it Class II
Sep 24, 2025Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/51721-ortho-clinical-vitros-lac-slides-recall-calibration-failures-risk-patient">Ortho-Clinical VITROS LAC Slides Recall: Calibration Failures Risk Patient Management (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-2560-2025 (July 29, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2560-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.