Recall Z-0476-2019 ยท MRR System, Test, Low Density, Lipoprotein
Ortho-Clinical Diagnostics
VITROS Chemistry Products dLDL Reagent-GENs 26 & 27. In Vitro Diagnostic to quantitatively measure LDL Cholesterol (LDLC) Product Code: 6801728 UDI (10758750006793)
| Date | Oct 8, 2018 |
| Status | Terminated |
| Reason | VITROS Chemistry Products dLDL Reagent GENs 26 and 27, negatively biased results |
| Root cause | Under Investigation by firm |
| Action | Ortho Clinical Diagnostics issue the customer notification on October 8, 2018, provides information regarding the potential for biased results when using VITROS dLDL Reagent, Generations (GENs) 26 and 27. Actions to take: For GEN 26: Discontinue using GEN 26 and switch to an alternate GEN of product as soon as possible. Please specify full or partial sales units remaining and indicate credit or replacement on your Confirmation of Receipt form. " For GEN 27: Install ADD DRV 6003 on your VITROS System upon receipt. Following a successful recalibration, resume using VITROS dLDL Reagent, GEN 27 r |
| Quantity | 5850 units |
| Distribution | Nationwide Foreign: Australia Belgium Bermuda, HM11 Brazil Canada L3R 4G5 Chile China Colombia Denmark France Germany India Italy Japan Mexico Norway Poland Portugal Russia Singapore Spain Sweden The Netherlands United Kingdom |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K041720 | VITROS CHEMISTRY PRODUCTS DLDL REAGENT, CALIBRATOR KIT 19, FS CALIBRATOR 1 AND PERFORMANCE VERIFIERS I AND II Ortho-Clinical Diagnostics, Inc., Aug 25, 2004 |