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U.S. Department of Health and Human Services

Class 2 Device Recall VITROS Chemistry Products LAC Slides

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 Class 2 Device Recall VITROS Chemistry Products LAC Slidessee related information
Date Initiated by FirmJuly 29, 2025
Date PostedSeptember 12, 2025
Recall Status1 Open3, Classified
Recall NumberZ-2560-2025
Recall Event ID 97409
510(K)NumberK955286 
Product Classification Acid, lactic, enzymatic method - Product Code KHP
ProductVITROS Chemistry Products LAC Slides. Catalog Number: 8150112. 1 Sales Unit = contains 5 cartridges of 18 slides, for a total of 90 tests.
Code Information 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
Recalling Firm/
Manufacturer		 Ortho-Clinical Diagnostics, Inc.
100 Indigo Creek Dr
Rochester NY 14626-5101
For Additional Information ContactLaurie O'Riordan
1-954-6239546
Manufacturer Reason
for 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.
FDA Determined
Cause 2		Device Design
ActionOn 29 July 2025, QuidelOrtho mailed a hardcopy customer letter (Ref. CL2025-201) via FedEx overnight courier and/ or electronically sent the customer letter using ORTHO PLUS e-Communications to customers. Consignees were instructed to load ADD DRV 6339 (or above) on your VITROS XT 3400 and/or VITROS XT 7600 System(s), complete and return the provided Confirmation of Receipt, save the 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, and forward the information if affected units were further distributed.
Quantity in Commerce2,320 units
DistributionUS Nationwide distribution.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = KHP
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