VITROS Chemistry Products dLDL Reagent-GENs 26 & 27. In Vitro Diagnostic to quantitatively measure LDL Cholesterol (LDLC) Product Code: 6801728 UDI (10758750006793)
FDA Recall Z-0476-2019 · Posted None
Recalling FirmOrtho-Clinical Diagnostics
Recall StatusTerminated
Product CodeMRR
Date Initiated2018-10-08
Date Terminated2022-10-13
Product Quantity5850 units
Reason for Recall
VITROS Chemistry Products dLDL Reagent GENs 26 and 27, negatively biased results
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 remaining in your inventory.
" Complete the Confirmation of Receipt form and return by October 22, 2018.
Questions contact our Ortho Care" Technical Solutions Center at 1-800-421-3311
Root Cause
Under Investigation by firm
Distribution Pattern
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
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.