Quick Facts at a Glance
- Recall Date
- July 29, 2025
- Hazard Level
- HIGH
- Brand
- Ortho-Clinical Diagnostics
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Ortho-Clinical Diagnostics
- Product type
- LAC Slides for VITROS XT 3400/7600 Systems
- Model numbers
- Catalog number 8150112, UDI# 10758750004454, Coating 0130 and above, Lot numbers 3533-0130-2947, 3533-0130-2972, 3533-0130-3001, 3533-0130-3002, 3533-0130-3048 +5 more
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
July 29, 2025
Reported by FDA DEVICE
September 24, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
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
About This Product
VITROS LAC Slides are used with VITROS XT analyzers to perform lactate analysis. They are delivered in sales units containing multiple slide cartridges intended for routine lab workflows.
Why This Is Dangerous
A calibration failure caused by certain lots and coating types can delay lactate test results, potentially affecting clinical decisions and patient management.
Industry Context
This recall appears limited to coating 0130 and above with TH4-63J on LAC slides for VITROS XT systems.
Real-World Impact
Delays in lactate test results can hinder timely patient management and treatment decisions in clinical settings.
Practical Guidance
How to identify if yours is affected
- Verify catalog number 8150112
- Check coating 0130 and above
- Review lot numbers 3533-0130-2947 through 3533-0131-6058
- Look for Condition Code TH4-63J on calibration logs
Where to find product info
Lot codes and coating information printed on product packaging and accompanying documentation; manufacturer recall letters provide confirmation.
What timeline to expect
Recall processing and replacements may take several weeks. Follow manufacturer instructions for replacements.
If the manufacturer is unresponsive
- Escalate to your hospital's purchasing or biosafety officer
- Contact the FDA recall complaint line if manufacturer support is slow
- Refer to FDA enforcement report for official guidance
How to prevent similar issues
- Verify coating type and lot numbers before use
- Maintain an updated log of recalled lots in inventory
- Coordinate with supplier for validated replacement lots
- Review supplier recall communications for any updates
Documentation advice
Keep recall letters, batch/lot records, calibration logs showing errors, and correspondence with the manufacturer.
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Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Laboratories nationwide affected
- Coating 0130 or higher with TH4-63J
- Calibration failures may delay lactate results
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Safety Guide
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