FDA Device recall Z-0450-2021
VITROS Immunodiagnostic Products-SARS-CoV-2 IgG Calibrator - Product Usage: In-Vitro Diagnostic (EUA) an aid in identifying individuals wit…
- FDA Device
- Class II
- terminated
- Published 2020-11-25
On 2020-11-25 the FDA classified a Class II recall of VITROS Immunodiagnostic Products-SARS-CoV-2 IgG Calibrator - Product Usage: In-Vitro Diagnostic (EUA) an aid in identifying individuals wit… by Ortho Clinical Diagnostics, citing elevated sample results signal/cutoff (s/c) values when using eight (8) lots of VITROS immunodiagnostic Products Anti-SARS-CoV-2 IgG Calibrator and decreased signal in one (1) lot….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0450-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-09-30 |
| Published | 2020-11-25 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Ortho Clinical Diagnostics |
| Distribution | US |
Product
VITROS Immunodiagnostic Products-SARS-CoV-2 IgG Calibrator - Product Usage: In-Vitro Diagnostic (EUA) an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. Emergency use of this test is limited to authorized laboratories-- Product Code (Unique Identifier): 6199920 (10758750033362)
Reason
Elevated sample results signal/cutoff (s/c) values when using eight (8) lots of VITROS immunodiagnostic Products Anti-SARS-CoV-2 IgG Calibrator and decreased signal in one (1) lot of VITROS¿ Immunodiagnostic Products Anti-SARS-CoV-2 IgG Control
Identifiers
| code_info | Lot Number/ Exp. Date: 0165 24-NOV-20 0180 19-NOV-20 0185 27-NOV-20 0190 21-NOV-20 0200 23-NOV-20 0205…Lot Number/ Exp. Date: 0165 24-NOV-20 0180 19-NOV-20 0185 27-NOV-20 0190 21-NOV-20 0200 23-NOV-20 0205 27-NOV-20 0220 03-DEC-20 0230 03-DEC-20 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0450-2021%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.