Recall Z-1113-2022— Ortho-Clinical Diagnostics, Inc
Class II · Ongoing
Class II FDA medical device recall by Ortho-Clinical Diagnostics, Inc, initiated 2022-03-25. It names one FDA 510(k) clearance: K964982. Product: VITROS Immunodiagnostic Products LH Reagent Pack Product Code: 1350198. 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..
- Recalling firm
- Ortho-Clinical Diagnostics, Inc
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2022-03-25
- Firm location
- Raritan, NJ, United States
510(k) clearances named in this recall
1 on FDA's record- K964982 — VITROS IMMUNODIAGNOSTICS PRODUCTS LH REAGENT PACK (GEM.1055) AND LH CALIBRATORS (GEM.CO55)
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
VITROS Immunodiagnostic Products LH Reagent Pack Product Code: 1350198
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.