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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
VITROS Black Reference Slides CATALOG #: J02316 - Product Usage: The Black Reference Slide is a part/ tool used in the reflectometer correction factor adjustment procedure.
Brand
Ortho-Clinical Diagnostics, INc.
Lot Codes / Batch Numbers
Lots: 9252-0058-3361, 9252-0058-3362
Products Sold
Lots: 9252-0058-3361, 9252-0058-3362
Ortho-Clinical Diagnostics, INc. is recalling VITROS Black Reference Slides CATALOG #: J02316 - Product Usage: The Black Reference Slide is a part due to Delayed results. Ortho confirmed that two lots of VITROS Black Reference Slides are incorrectly labelled as White Reference Slides. If the customer f. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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 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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026