Ortho Clinical Diagnostics Inc Recall 87028
Description: 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.
Ortho Clinical Diagnostics Inc Recall 87028 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0770-2021 |
| Event ID | 87028 |
| Event Description | 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. |
| Product Type | Devices |
| 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. |
| Quantity | Total: 41,598 U.S. = 403 xU.S. = 41,195 |
| Recall Reason | VITROS Chemistry Products CKMB Slides Potential for Falsely Elevated Results Due to CK-MM Interference |
| Device Classification | 20210113 |
| Device Code Info | Coatings 0230, 0231, 0233, 0235, 0239 (all lot numbers) UDI: (1) (10758750004294) (2) (10758750004201 |
| Center Classification Date | 20210105 |
| Recall Initiation Date | 20201211 |
| Recalling Firm | Ortho Clinical Diagnostics Inc |
| Initial Notification | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
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