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, PREGNANT
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
- Laboratory Reagents / Slides
- Model numbers
- Catalog number 8433880, UDI# 110758750004911, Coating 0130 and above, Lot numbers 3533-0130-2317 to 3533-0131-6128
- 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
LAC Slides are used in chemistry testing on VITROS analyzers to perform lactate dehydrogenase tests; this recall concerns calibration reliability rather than direct product failure causing patient harm.
Why This Is Dangerous
Calibration failures can delay results, potentially affecting clinical decisions and patient management.
Industry Context
This recall is not described as part of a broader pattern.
Real-World Impact
Delays in lab results may affect treatment timelines and patient management; facilities should verify stock and contact the manufacturer for guidance.
Practical Guidance
How to identify if yours is affected
- Check catalog number 8433880
- Verify coating designation 0130 and above and TH4-63J code
Where to find product info
FDA recall page and Ortho-Clinical Diagnostics communications
What timeline to expect
Refunds/replacements timelines vary; follow manufacturer guidance
If the manufacturer is unresponsive
- Escalate to hospital procurement or regulatory bodies; document communications; seek alternative supplier if needed.
- Consider filing with CPSC or FDA if necessary.
How to prevent similar issues
- Implement inventory checks for coating versions; verify lot-specific risk before use; maintain alternative stock
- Stay updated with FDA recall notices and manufacturer alerts
Documentation advice
Keep recall notice, lot lists, and correspondence; document affected stock with location and quantity
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Product Details
Catalog number 8433880. 1 Sales Unit = 5 cartridges of 60 slides, total 300 tests. Quantity recalled: 2,908 units. UDI: 110758750004911. Coating 0130 and above. Lot numbers 3533-0130-2317 through 3533-0131-6128. Sold/distributed nationwide in the US.
Reported Incidents
No specific injury or patient harm counts are provided in the summary. The hazard is described as calibration failure and potential impact on patient management.
Key Facts
- Coating 0130+ linked to TH4-63J
- Calibrations delays may affect patient management
- US nationwide distribution
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Safety Guide
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