HIGH

Ortho-Clinical Diagnostics Recalls LAC Slides Due to Calibration Failures

Ortho-Clinical Diagnostics recalled 2,320 units of VITROS Chemistry Products LAC Slides on July 29, 2025. Calibration failures in lots from coating 0130 and above delay test results and may impact patient management. Healthcare providers and patients must stop using these slides immediately.

Quick Facts at a Glance

Recall Date
July 29, 2025
Hazard Level
HIGH
Brand
Ortho-Clinical Diagnostics
Category
Health & Personal Care
Sold At
Unknown
Geographic Scope
1 states
At-Risk Groups
GENERAL

Hazard Information

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.

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Ortho-Clinical Diagnostics, Inc. or your healthcare provider for instructions. Notification method: Letter

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Product Details

The recalled product is VITROS Chemistry Products LAC Slides, Catalog Number 8150112. Each sales unit contains 5 cartridges of 18 slides, totaling 90 tests. The distribution of this product occurred nationwide in the United States.

The Hazard

Calibration failures in the LAC Slides can delay lactate test results. Customers reported an average failure rate of 1% for coating 0130 in 2025, significantly higher than the 0.06% failure rate for other coatings in the same year.

What to Do

Stop using the VITROS Chemistry Products LAC Slides immediately. Contact Ortho-Clinical Diagnostics, Inc. or your healthcare provider for further instructions and follow the provided recall instructions.

Contact Information

For more details, patients and healthcare providers can visit the recall page at the FDA website or contact Ortho-Clinical Diagnostics.

Key Facts

  • Recall Date: July 29, 2025
  • Report Date: September 24, 2025
  • Class II recall status
  • Total quantity recalled: 2,320 units

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Details

Model Numbers
Catalog number 8150112
UDI# 10758750004454
Coating 0130 and above
Lot numbers 3533-0130-2947
3533-0130-2972
+8 more
Affected States
ALL
Report Date
September 24, 2025
Recall Status
ACTIVE

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