Recall Z-2623-2023 ยท CIG Diazo Colorimetry, Bilirubin
Ortho-Clinical Diagnostics, INc.
VITROS XT Chemistry Products TBIL-ALKP Slides
| Date | Sep 21, 2023 (initiated Aug 5, 2023) |
| Status | Open, Classified |
| 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. |
| Root cause | 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 |
| Quantity | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K190807 | VITROS XT Chemistry Products TBIL-ALKP Slides Ortho-Clinical Diagnostics, Inc., Apr 26, 2019 |