Ortho-Clinical Diagnostics, INc. Recall 92928
Description: VITROS XT Chemistry Products ALKP Slides
Ortho-Clinical Diagnostics, INc. Recall 92928 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2624-2023 |
| Event ID | 92928 |
| Event Description | VITROS XT Chemistry Products ALKP Slides |
| Product Type | Devices |
| 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 |
| Quantity | 402,966 units |
| Recall 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. |
| Device Classification | 20230927 |
| Device Code Info | 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 |
| Center Classification Date | 20230921 |
| Recall Initiation Date | 20230805 |
| Recalling Firm | Ortho-Clinical Diagnostics, INc. |
| Initial Notification | Letter |
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