—#168397

Product

VITROS Chemistry Products dLDL Reagent-GENs 26 & 27. In Vitro Diagnostic to quantitatively measure LDL Cholesterol (LDLC) Product Code: 6801728 UDI (10758750006793)

FDA product code: MRR — System, Test, Low Density, Lipoprotein
Device class: Class 1
Medical specialty: Clinical Chemistry
510(k) numbers: K041720
Affected lot / code info: Lot Numbers: 1517-26-6396 (expires 6-Nov-2018) 1517-26-6582 (expires 2-Feb-2019) 1517-26-6639 (expires 2-Feb-2019) 1517-27-6808 (expires 7-May-2019)

Why it was recalled

VITROS Chemistry Products dLDL Reagent GENs 26 and 27, negatively biased results

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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

Recalling firm

Firm: Ortho-Clinical Diagnostics
Address: 100 Indigo Creek Dr, Rochester, New York 14626-5101

Distribution

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

Timeline

Recall initiated: 2018-10-08
Terminated: 2022-10-13
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #168397. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.