The Recall Desk
HighFDA (Devices)·Z-1113-2022·Announced 2022-05-25

FDA Recalls VITROS Immunodiagnostic LH Reagent Pack for measurement imprecision

Ortho-Clinical Diagnostics is recalling VITROS Immunodiagnostic Products LH Reagent Pack due to low-end imprecision that may produce falsely high or delayed patient and quality control 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 a FDA Class II recall affecting a laboratory diagnostic reagent with potential to produce inaccurate patient test results through calibration imprecision. No illnesses, injuries, or deaths have been reported. The hazard is theoretical and fits the Score 3 criterion as a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Ortho-Clinical Diagnostics, Inc. is recalling the VITROS Immunodiagnostic Products LH (Luteinizing Hormone) Reagent Pack (Product Code 1350198) distributed worldwide.

The reagent pack exhibits low-end imprecision when measuring quality control and patient samples at the low end of the measuring range. This imprecision, driven by calibration failures with Calibrator Level 1, can result in falsely high or delayed test results.

The recall affects 1575 units: 1183 distributed in the United States and 392 distributed internationally to Australia, Bermuda, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Netherlands, Norway, Portugal, Russia, Singapore, Spain, Sweden, and the United Kingdom. Affected lot numbers 1910 through 1960 have expiration dates from August 2022 through January 2023. Future production lots are also affected until further notice.

Laboratories and healthcare providers using affected reagent packs should verify their lot numbers and contact Ortho-Clinical Diagnostics for replacement products or further guidance.

The recalled product

Product
VITROS Immunodiagnostic Products LH Reagent Pack Product Code: 1350198
Manufacturer
Ortho-Clinical Diagnostics, Inc
Category
Medical Device — Laboratory Reagent / Immunodiagnostic
Hazard
  • low-end-imprecision
  • inaccurate-results
  • calibration-failure

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 (1)

  • Until further notice

Distribution

Distributed nationwide across the United States.

Related recalls

Same category