Class 2 Device Recall Ortho Clinical Diagnostics (OCD) VITROS Chemistry Products CKMB Slides

• Date Initiated by Firm: December 11, 2020
• Create Date: January 05, 2021
• Recall Status: Open, Classified
• Recall Number: Z-0770-2021
• Recall Event ID: 87028
• 510(K)Number: k861387
• Product Classification: Differential rate kinetic method, cpk or isoenzymes - Product Code JHS
• Product: VITROS Chemistry Products CKMB Slides:; ; (1)VITROS CKMB Slides (60 Slide cartridge); Product Code:8058232 ; ; (2)VITROS CKMB Slides (18 Slide cartridge); Product Code: 8001133; ; Quantitatively measure creatine kinase MB (CK-MB) activity in serum using VITROS 250/350/5,1 FS/4600/XT 3400 Chemistry Systems and the VITROS 5600/XT 7600 Integrated Systems.
• Code Information: Coatings 0230, 0231, 0233, 0235, 0239 (all lot numbers) UDI: (1) (10758750004294) (2) (10758750004201
• Recalling Firm/ Manufacturer: Ortho Clinical Diagnostics Inc; 1001 US Highway 202; Raritan NJ 08869-1424
• For Additional Information Contact: Ortho Care Technical Solutions; 800-421-3311
• Manufacturer Reason for Recall: VITROS Chemistry Products CKMB Slides Potential for Falsely Elevated Results Due to CK-MM Interference
• FDA Determined Cause: Under Investigation by firm
• Action: Ortho Clinical Diagnostics (OCD) issued Urgent Product Correction Notification (CL2020-302) via ORTHO PLUSSM ( e-Communications, on 11 December 2020 to consignees. Letter states reason for recall, health risk and action to take: Per the VITROS CKMB Slides IFU, evaluate the Total CK value of the sample. For the respective CKMB coating, elevated total CK activity (>300 and <1000 U/L) may cause a significantly elevated VITROS CKMB Slides result. If the CK activity exceeds the value listed in the table on page 1, consult with your Medical Director. " Depending on which coating is used in your laboratory, you may want to consider an alternate method for samples with CK activity greater than indicated in the table on page 1. " If your laboratory chooses to discontinue using an affected coating, Ortho will credit your account. Current inventory levels do not allow for replacement. Provide credit quantity information using the Confirmation of Receipt form. " Complete the enclosed Confirmation of Receipt form no later than 22-DEC-2020. Note: complete the form even if your laboratory no longer has inventory of affected product. " Please forward this notification if the product was distributed outside of your facility. A VITROS CKMB Slides coating is currently being manufactured and is expected to be available in the first quarter of 2021. Ortho will continue to perform testing on all future coatings to evaluate CK-MM inhibition and will update the Technical Bulletin as appropriate. If you have further questions, please contact Ortho Care" Technical Solutions Center at 1-800-421-3311
• Quantity in Commerce: Total: 41,598 U.S. = 403 xU.S. = 41,195
• Distribution: Worldwide distribution - US Nationwide distribution and the countries of Australia, Brazil, Canada, Chile, China, Colombia, India, Japan, Mexico, Singapore 609917, United Kingdom, France, Germany, Italy, Spain, Portugal, Poland, Russia, Denmark, Norway, Sweden, Belgium, The Netherlands.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = JHS and Original Applicant = EASTMAN KODAK COMPANY