The Recall Desk
HighFDA (Devices)·Z-0878-2023·Announced 2023-01-11

VITROS Intact PTH Reagent Pack recalled for negatively biased measurement results

Ortho-Clinical Diagnostics is recalling VITROS Intact PTH Reagent Packs due to negatively biased measurement results (average -12% shift). The affected reagent lots were distributed worldwide and may produce inaccurate patient test results.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall of a diagnostic device producing systematically biased measurement results (average -12% negative shift). While no illnesses or injuries have been reported, the measurement inaccuracy poses a risk of diagnostic error affecting patient care decisions, fitting the rubric criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Ortho-Clinical Diagnostics, Inc. is recalling the VITROS Immunodiagnostic Products Intact PTH Reagent Pack (Catalog Number 6802892), a diagnostic reagent used to measure intact parathyroid hormone (iPTH) levels in serum and plasma samples. A total of 4,158 units have been affected and distributed worldwide to the United States and multiple international locations.

The recall was initiated due to negatively biased measurement results in the affected reagent lots. Laboratory and quality control testing revealed that patient iPTH results were systematically lower than expected, with an average -12% shift. This measurement inaccuracy could result in misinterpretation of patient test results and affect clinical decision-making.

The affected lot numbers are: 1610 (expires 24-Apr-2023), 1621 (expires 24-Apr-2023), 1630 (expires 08-May-2023), 1640 (expires 08-May-2023), 1645 (expires 08-May-2023), 1650 (expires 29-May-2023), and 1670 (expires 06-Jun-2023). The products carry UDI-DI 6802892 (10758750006267).

Laboratories and healthcare facilities using these reagent lots should discontinue use immediately and contact Ortho-Clinical Diagnostics for replacement reagents or further instructions. Review any test results obtained using the affected lots to ensure appropriate patient care.

The recalled product

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
Manufacturer
Ortho-Clinical Diagnostics, Inc.
Category
Medical Device — Diagnostic Reagent
Hazard
  • measurement-bias
  • diagnostic-inaccuracy

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (7)

  • UDI-DI: 6802892 (10758750006267) Lot Numbers/Exp Date: 1610 24-Apr-2023
  • 1621 24-Apr-2023
  • 1630 08-May-2023
  • 1640 08-May-2023
  • 1645 08-May-2023
  • 1650 29-May-2023
  • 1670 06-Jun-2023

Distribution

Distributed nationwide across the United States.

Related recalls

Same category