Z-2624-2023 Class II Ongoing
FDA device recall Z-2624-2023 was initiated by Ortho-Clinical Diagnostics, INc. on August 5, 2023 and is designated Class II. 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, w… The recall status is ongoing. Affected quantity: 402,966 units.
Recall Details
- Product Type
- Devices
- Report Date
- September 27, 2023
- Initiation Date
- August 5, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 402,966 units
Product Description
VITROS XT Chemistry Products ALKP Slides
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.
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
Code Information
Product Code: 1053180 UDI:(10758750008346) GEN #21; Expiry Date Range 01 Jul 2023 - 01 June 2024 GEN #23; Expiry Date Range 01 Oct 2023 - 01 Sep 2024 GEN #26; Expiry Date Range 01 Aug 2023 - 01 Dec 2024 GEN #28; Expiry Date Range 01 Aug 2024 GEN #29; Expiry Date Range 01 Sep 2024 - 01 Dec 2024 GEN #30; Expiry Date Range 02 Jan 2025