VITROS Immunodiagnostic Products FSH Reagent Pack- IVD 1931922
Reported: May 25, 2022 Initiated: March 25, 2022 #Z-1112-2022
Product Description
VITROS Immunodiagnostic Products FSH Reagent Pack- IVD 1931922
Reason for Recall
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.
Details
- Recalling Firm
- Ortho-Clinical Diagnostics, Inc
- Units Affected
- 2502 total: 2154 US; 348 OUS
- Distribution
- 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
- Location
- Raritan, NJ
Frequently Asked Questions
What product was recalled? ▼
VITROS Immunodiagnostic Products FSH Reagent Pack- IVD 1931922. Recalled by Ortho-Clinical Diagnostics, Inc. Units affected: 2502 total: 2154 US; 348 OUS.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 25, 2022. Severity: Moderate. Recall number: Z-1112-2022.
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