Device product
VITROS XT Chemistry Products TBIL-ALKP Slides
Z-2623-2023
Product summary
- Event
- Event 92928
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 52,456 units
- Official record key
device-enforcement:Z-2623-2023
Official wording
Reason: 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.
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
Distribution pattern: 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
Derived failure modes
-
Unknown
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.