Recall Z-1316-2012 ยท LBS Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl
Ortho-Clinical Diagnostics
VITROS Chemistry Products --- dHDL Slides --- Ortho Clinical Diagnostics, a Johnson&Johnson company --- [Mfg Symbol] Ortho-Clinical Diagnostics, Inc., Rochester, NY USA --- VITROS dHDL Slides are used to quantitatively measure HDL cholesterol (HDLC) concentration in serum and plasma using VITROS Chemistry and Integrated Systems. --- Product codes: 6801895 (60 slide count); 6802469 (18 slide count)
| Date | Mar 26, 2012 (initiated Feb 2, 2012) |
| Status | Terminated |
| Reason | Ortho Clinical Diagnostics (OCD) has revised the VITROS dHDL Slides Instructions for Use (IFU) and removed EDTA plasma as a recommended sample type. |
| Root cause | Device Design |
| Action | Ortho Clinical Diagnostics sent an Important Product Information letter dated February 2, 2012, to all affected customers via Federal Express overnight mail. The letter informed customers of the issue, notifying them of the removal of EDTA plasma as a recommended sample type and providing the revised VITROS dHDL Slides Instructions for Use. J&J Foreign affiliate consignees were notified by email informing them of the issue on 02 February 2012. Customers were instructed to replace the current pages in their VITROS Chemistry Products Instructions for Use Manual with the updated instructions f |
| Quantity | 120,225 of 60-slide count, 11.364 of 18-slide count |
| Distribution | Worldwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K042006 | VITROS CHEMISTRY PRODUCTS DHDL SLIDES, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 25, VITROS CHEMISTRY PRODUCTS PERFORMACE Ortho-Clinical Diagnostics, Inc., Oct 28, 2004 |