Recall Z-1113-2022 ยท CEP Radioimmunoassay, Luteinizing Hormone
Ortho-Clinical Diagnostics, Inc
VITROS Immunodiagnostic Products LH Reagent Pack Product Code: 1350198
| Date | Mar 25, 2022 |
| Status | Open, Classified |
| 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. |
| Root cause | Device Design |
| Action | Ortho CLinical Diagnostics issued "URGENT PRODUCT CORRECTION NOTIFICATION" dated 3/25/22 to consignees who had been shipped VITROS FSH, LH or Prol in the previous 18 months were notified (CL2022-069) of the issue and instructed as follows: -Run daily low-level QC in duplicate to confirm acceptable performance. -If their laboratory is experiencing low end imprecision with VITROS FSH, LH or Prol Reagent, follow one of the suggested testing algorithms as described in the enclosure. o Note: If their laboratory is not experiencing low end imprecision, continue testing patient samples as usual (sing |
| Quantity | 1575 units total: 1183 US; 392 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K964982 | VITROS IMMUNODIAGNOSTICS PRODUCTS LH REAGENT PACK (GEM.1055) AND LH CALIBRATORS (GEM.CO55) Johnson & Johnson Clinical Diagnostics, Inc., Feb 20, 1997 |