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Terminated

VITROS Black Reference Slides CATALOG #: J02316 - Product Usage: The Black Reference Slide is a part/ tool used in the reflectometer correction factor adjustment procedure.

FDA Recall Z-1489-2021 · Posted None

Recalling FirmOrtho-Clinical Diagnostics, INc.
Recall StatusTerminated
Product CodeN/A
Date Initiated2021-03-26
Date Terminated2023-05-24
Product Quantity865 units of 25 slides each

Reason for Recall

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.

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.

Root Cause

Under Investigation by firm

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K182063VITROS Chemistry Products CRBM Slides, VITROS Chemistry Products CREA Slides, VITROS Chemistry Products TBIL Slides, VITROS XT 7600 Integrated SystemOrtho-Clinical Diagnostics, Inc. · 2018-10-30

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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