FDA Device recall Z-1114-2022
VITROS Immunodiagnostic Products Prolactin Reagent Pack Product Code: 1849793
- FDA Device
- Class II
- ongoing
- Published 2022-05-25
On 2022-05-25 the FDA classified a Class II recall of VITROS Immunodiagnostic Products Prolactin Reagent Pack Product Code: 1849793 by Ortho Clinical Diagnostics, citing falsely high or delayed patient and QC results may occur due to low end imprecision. VITROS Immunodiagnostic Products FSH, LH and Prol Reagents Low End Imprecision. Low-level qual….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1114-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-03-25 |
| Published | 2022-05-25 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Ortho Clinical Diagnostics |
| Distribution | US |
Product
VITROS Immunodiagnostic Products Prolactin Reagent Pack Product Code: 1849793
Reason
Falsely high or delayed patient and QC results may occur due to low end imprecision. VITROS Immunodiagnostic Products FSH, LH and Prol Reagents Low End Imprecision. Low-level quality control (QC) and patient samples at the low end of the Measuring (Reportable) Range when using VITROS FSH, LH and Prol Reagent. Calibration failures, driven by imprecision observed with Calibrator Level 1.
Identifiers
| code_info | Until further notice, future lots will also be affected. UDI: 10758750000111 Affected Lot Number/ Expiration Date: 2840…Until further notice, future lots will also be affected. UDI: 10758750000111 Affected Lot Number/ Expiration Date: 2840 13-MAY-2022; 2850 08-JUN-2022; 2860 02-JUL-2022; 2870 17-JUL-2022; 2875 17-JUL-2022; 2880 14-SEP-2022; 2891 28-SEP-2022; 2900 29-OCT-2022; |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1114-2022%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.