Recall Z-0770-2021 ยท JHS Differential Rate Kinetic Method, Cpk Or Isoenzymes
Ortho Clinical Diagnostics Inc
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.
| Date | Jan 5, 2021 (initiated Dec 11, 2020) |
| Status | Open, Classified |
| Reason | VITROS Chemistry Products CKMB Slides Potential for Falsely Elevated Results Due to CK-MM Interference |
| Root 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 lab |
| Quantity | Total= 41,598 U.S. = 403 xU.S. = 41,195; Extended: 25,775 units |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K861387 | KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (CK-MB) Eastman Kodak Company, Jun 27, 1986 |