Ortho-Clinical Diagnostics, INc. Recall 87649
Description: VITROS¿ Black Reference Slides CATALOG #: J02316 - Product Usage: The Black Reference Slide is a part/ tool used in the reflectometer correction factor adjustment procedure.
Ortho-Clinical Diagnostics, INc. Recall 87649 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1489-2021 |
| Event ID | 87649 |
| Event Description | VITROS¿ Black Reference Slides CATALOG #: J02316 - Product Usage: The Black Reference Slide is a part/ tool used in the reflectometer correction factor adjustment procedure. |
| Product Type | Devices |
| 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, India, Japan, Mexico, Singapore, United Kingdom, France, Germany, Italy, Spain, Portugal, Poland, Russia, Denmark, Norway, Sweden, Belgium, The Netherlands. |
| Quantity | 865 units of 25 slides each |
| Recall 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 doesn t have any White Reference Slides in reserve, they can t run the Correction Factor test correctly and get the analyzer running again until they get more White Reference Slides delivered. This could lead to a delay in results for all Vitros assays except for sodium, potassium, and chloride. |
| Device Classification | 20210505 |
| Device Code Info | Lots: 9252-0058-3361, 9252-0058-3362 |
| Center Classification Date | 20210423 |
| Recall Initiation Date | 20210326 |
| Recalling Firm | Ortho-Clinical Diagnostics, INc. |
| Initial Notification | Letter |
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