Z-0476-2019Class II

VITROS Chemistry Products dLDL Reagent-GENs 26 & 27. In Vitro Diagnostic to quantitatively measure LDL...

Name: Z-0476-2019 VITROS Chemistry Products dLDL Reagent-GENs 26 & 27. In Vitro Diagnostic to quantitatively measure LDL...
Creator: Ortho-Clinical Diagnostics
Published: 2018-10-08
License: https://open.fda.gov/license/

Ortho-Clinical Diagnostics, Inc. / initiated 2018-10-08 / Terminated

FDA source

Ortho-Clinical Diagnostics began a recall of VITROS Chemistry Products dLDL Reagent-GENs 26 & 27. In Vitro Diagnostic to quantitatively measure LDL Cholesterol (LDLC) Product Code: 6801728 UDI... on 2018-10-08. FDA classified it as Class II and gives the reason as "VITROS Chemistry Products dLDL Reagent GENs 26 and 27, negatively biased results". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0476-2019
Classification: Class II
Status: Terminated
Initiated: 2018-10-08
Posted: 2018-11-17
Terminated: 2022-10-13
Recalling firm: Ortho-Clinical Diagnostics, Inc.
Product: VITROS Chemistry Products dLDL Reagent-GENs 26 & 27. In Vitro Diagnostic to quantitatively measure LDL Cholesterol (LDLC) Product Code: 6801728 UDI (10758750006793)
Product code: MRR System, Test, Low Density, Lipoprotein
Reason for recall: VITROS Chemistry Products dLDL Reagent GENs 26 and 27, negatively biased results
FDA 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 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
Quantity in commerce: 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
Product codes and lots: 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)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0476-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0476-2019	Class II	Terminated	Voluntary: Firm initiated	2018-11-28	2018-11-16

Product code MRR

K041720Class IVitros Chemistry Products Dldl Reagent, Calibrator Kit 19, Fs Calibrator 1 and Performance Verifiers I and IIOrtho-Clinical Diagnostics, Inc. / cleared 2004-08-25

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)