Recall Z-0878-2023— Ortho-Clinical Diagnostics, Inc.

Name: FDA recall Z-0878-2023
Creator: U.S. Food and Drug Administration
Published: 2022-11-17

Class II · Ongoing

Class II FDA medical device recall by Ortho-Clinical Diagnostics, Inc., initiated 2022-11-17. It names one FDA 510(k) clearance: K101921. Product: VITROS Immunodiagnostic Products Intact PTH Reagent Pack- IVD For the quantitative measurement of intact parathyroid hormone (iPTH) in human serum and plasma (EDTA or heparin) Catalog Number: 6802892. Reason: Lower than expected iPTH patient and Quality Control (QC) results, reported negatively biased iPTH results- an average -12% shift in patient sample results.

Recalling firm: Ortho-Clinical Diagnostics, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2022-11-17
Firm location: Rochester, NY, United States

510(k) clearances named in this recall

1 on FDA's record

K101921 — VITROS IMMUNODIAGNOSTICS PRODUCTS INTACT PTH REAGENT PACK, VITROS IMMUNODIAGNOSTICS PRODUCTS INTACT PTH CALIBRATORS, VITOrtho-Clinical Diagnostics·cleared 2010-10-22

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 Intact PTH Reagent Pack- IVD For the quantitative measurement of intact parathyroid hormone (iPTH) in human serum and plasma (EDTA or heparin) Catalog Number: 6802892

Reason for recall

Lower than expected iPTH patient and Quality Control (QC) results, reported negatively biased iPTH results- an average -12% shift in patient sample results

Data sourced from openFDA. This site is unofficial and independent of the FDA.