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U.S. Department of Health and Human Services

Class 2 Device Recall VITROS TBILALKP Slides

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  Class 2 Device Recall VITROS TBILALKP Slides see related information
Date Initiated by Firm August 05, 2023
Date Posted September 21, 2023
Recall Status1 Open3, Classified
Recall Number Z-2623-2023
Recall Event ID 92928
510(K)Number K190807  
Product Classification Diazo colorimetry, bilirubin - Product Code CIG
Product VITROS XT Chemistry Products TBIL-ALKP Slides
Code Information Product Code: 6844296 UDI: (10758750031801) GEN #16; Expiry Date Range 01 Jul 2023 - 01 Sep 2023 GEN #17; Expiry Date Range 01 Nov 2023 - 01 Feb 2024 GEN #18; Expiry Date Range 01 Apr 2024 - 01 Aug 2024 GEN #19; Expiry Date Range 01 Aug 2024 - 01 Jan 2025
Recalling Firm/
Manufacturer		 Ortho-Clinical Diagnostics, INc.
513 Technology Blvd
Rochester NY 14626-3601
For Additional Information Contact Joe Falvor
585-453-4224
Manufacturer Reason
for Recall		 Samples containing high levels of ALKP (or an interfering substance) could deplete the available substrate in the reagent layer of a VITROS ALKP Slide and not post the substrate deleption (DP) code, which may result in the System reporting an incorrect value (lower than the actual value), which may result in missed or delayed diagnosis of liver disease.
FDA Determined
Cause 2		 Under Investigation by firm
Action An "IMPORTANT PRODUCT CORRECTION NOTIFICATION" letter dated 08/17/2023 was issued to impacted consignees. Consignees are provided instructions to utilize when reviewing sample results and any result between 600-1500 U/L should be diluted using a 10x dilution and retested. A confirmation of receipt of the recall letter should be completed and returned by August 25, 2023. Please forward this notification if the affected product was distributed outside your facility. Save this notification with your documentation or post this notification by each VITROS 250/350/FS 5,1/4600/5600/XT 3400/XT 7600 System until the issue has been resolved. If your laboratory has experienced this issue with the product and has not already done so, please report the occurrence to your local Ortho Care Technical Solutions Center. If you have further questions, please contact our Global Services Organization at 1-800-421-3311.
Quantity in Commerce 52,456 units
Distribution Worldwide Distribution: US (nationwide) and OUS (foreign) distribution to countries of: Bermuda, Belgium, Australia, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, Italy, India, Japan, Mexico, Netherlands, Norway, Singapore, Spain, Sweden, Portugal, Russia, United Kingdom
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = CIG and Original Applicant = Ortho-Clinical Diagnostics, Inc.
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