Recall Z-1489-2021 ยท N/A
Ortho-Clinical Diagnostics, INc.
VITROS Black Reference Slides CATALOG #: J02316 - Product Usage: The Black Reference Slide is a part/ tool used in the reflectometer correction factor adjustment procedure.
| Date | Mar 26, 2021 |
| Status | Terminated |
| Reason | Delayed results. Ortho confirmed that two lots of VITROS Black Reference Slides are incorrectly labelled as White Reference Slides. If the customer fails to notice both the product name or the unexpected color of the slides and tries to use Black Reference Slides as White Reference Slides, the Correction Factor test will fail - and the analyzer will not be able to produce results for any assays other than sodium, potassium, and chloride. If the customer doesnt have any White Reference Slides in reserve, they cant run the Correction Factor test correctly and get the analyzer running again unt |
| Root cause | Under Investigation by firm |
| Action | On 3/25/2021, Ortho Clinical Diagnostics issued an Urgent Medical Device Correction notice via letter notifying customers two lots of the VITROS Black Reference Slides have the incorrect part number on the box. |
| Quantity | 865 units of 25 slides each |
| Distribution | Worldwide distribution - US Nationwide distribution in the states of AL, AR, CA, CO, CT, FL GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, ND, NE, NH, NJ, NY, OH, OK, PA, SC, TN, TX, VA, WA, WI, WV, WY and the countries of Australia, Bermuda, Brazil, Canada, China, Colombia, Ind |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K182063 | VITROS Chemistry Products CRBM Slides, VITROS Chemistry Products CREA Slides, VITROS Chemistry Products TBIL Slides, VIT Ortho-Clinical Diagnostics, Inc., Oct 30, 2018 |