VITROS recallZ-2623-2023 · Ortho-Clinical Diagnostics, INc. · initiated Aug 5, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Ortho-Clinical Diagnostics, INc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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 root cause category: Under Investigation by firm
What the company is doing
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.
Recall details
- Recall number
- Z-2623-2023
- Status
- Open, Classified
- Initiated by the company
- Aug 5, 2023
- Posted by the FDA
- Sep 21, 2023
- Recalling firm
- Ortho-Clinical Diagnostics, INc.
- Quantity
- 52,456 units
- Product code
- CIG
- FDA submissions
- K190807
- 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
Product description
VITROS XT Chemistry Products TBIL-ALKP Slides
Code information (models, lots, serial numbers)
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
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- VITROS 6844296Ortho-Clinical Diagnostics, Inc. · NITROPHENYLPHOSPHATE, ALKALINE PHOSPHATASE OR ISOENZYMES4 recalls0 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 92928).
- Z-2624-2023 · Open, ClassifiedVITROS XT Chemistry Products ALKP Slides
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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