FDA Device recall Z-0476-2019
VITROS¿ Chemistry Products dLDL Reagent-GENs 26 & 27
- FDA Device
- Class II
- terminated
- Published 2018-11-28
On 2018-11-28 the FDA classified a Class II recall of VITROS¿ Chemistry Products dLDL Reagent-GENs 26 & 27 by Ortho Clinical Diagnostics, citing VITROS Chemistry Products dLDL Reagent GENs 26 and 27, negatively biased results.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0476-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-10-08 |
| Published | 2018-11-28 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Ortho Clinical Diagnostics |
| Distribution | US |
Product
VITROS¿ Chemistry Products dLDL Reagent-GENs 26 & 27. In Vitro Diagnostic to quantitatively measure LDL Cholesterol (LDLC) Product Code: 6801728 UDI (10758750006793)
Reason
VITROS Chemistry Products dLDL Reagent GENs 26 and 27, negatively biased results
Identifiers
| 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) |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0476-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.