Device product
VITROS Immunodiagnostic Products Prolactin Reagent Pack Product Code: 1849793
Z-1114-2022
Product summary
- Event
- Event 90047
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1767 units total: 1521 US; 246 OUS
- Official record key
device-enforcement:Z-1114-2022
Official wording
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.
Code information: 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;
Distribution pattern: Worldwide Distribution: US (Nationwide) OUS (Foreign): Australia Bermuda Brazil Canada L3R 4G5 Chile China Colombia Denmark France Germany India Italy Japan Mexico Netherlands Norway Portugal Russia Singapore Spain Sweden United Kingdom
Derived failure modes
-
Unknown
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.