Z-0476-2019 Class II Terminated
FDA device recall Z-0476-2019 was initiated by Ortho-Clinical Diagnostics on Oct 8, 2018 and is designated Class II. Reason for recall: VITROS Chemistry Products dLDL Reagent GENs 26 and 27, negatively biased results The recall status is terminated (terminated Oct 13, 2022). Affected quantity: 5850 units.
Recall Details
- Product Type
- Devices
- Report Date
- Nov 28, 2018
- Initiation Date
- Oct 8, 2018
- Termination Date
- Oct 13, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5850 units
Product Description
VITROS¿ Chemistry Products dLDL Reagent-GENs 26 & 27. In Vitro Diagnostic to quantitatively measure LDL Cholesterol (LDLC) Product Code: 6801728 UDI (10758750006793)
Reason for Recall
VITROS Chemistry Products dLDL Reagent GENs 26 and 27, negatively biased results
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
Code Information
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)
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0476-2019
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026