The Recall Desk
HighFDA (Devices)·Z-1112-2022·Announced 2022-05-25

VITROS Immunodiagnostic Hormone Reagents Recalled for Measurement Imprecision

Specific lots of VITROS FSH, LH, and Prolactin reagent kits may produce falsely high or delayed test results at low measurement levels. Affected lots distributed worldwide; labs should discontinue use and contact the manufacturer.

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: FDA Class II diagnostic reagent recall with identified measurement imprecision that may cause falsely high or delayed test results, affecting clinical decision-making. No illnesses or adverse events have been reported, but the product presents a risk of harm through diagnostic inaccuracy.

Plain-English summary

Ortho-Clinical Diagnostics, Inc. is recalling specific lots of VITROS Immunodiagnostic Products FSH, LH, and Prolactin Reagent Packs used in clinical laboratories to measure hormone levels in blood samples.

The recalled lots have measurement imprecision at low test levels, which can cause falsely high hormone results or delayed test results. This imprecision is caused by calibration failures in the test system. Until further notice, future lots are also affected by this issue.

A total of 2,502 affected kits were distributed—2,154 in the United States and 348 internationally across multiple countries. Laboratories using the affected lot numbers should stop using them immediately and contact the manufacturer for replacements.

Contact Ortho-Clinical Diagnostics for replacement kits and further guidance. The FDA has classified this as a Class II recall. A complete list of affected lot numbers and expiration dates is available on the FDA website.

The recalled product

Product
VITROS Immunodiagnostic Products FSH Reagent Pack- IVD 1931922
Manufacturer
Ortho-Clinical Diagnostics, Inc
Category
Medical Device — Laboratory Reagent
Hazard
  • measurement-imprecision
  • calibration-failure
  • 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 (13)

  • Until further notice
  • 3111 25-MAR-2022
  • 3120 04-APR-2022
  • 3130 25-APR-2022
  • 3140 10-MAY-2022
  • 3145 10-MAY-2022
  • 3150 30-MAY-2022
  • 3160 09-JUN-2022
  • 3170 22-JUN-2022
  • 3180 02-AUG-2022
  • 3190 16-AUG-2022
  • 3200 06-SEP-2022
  • 3210 12-SEP-2022.

Distribution

Distributed nationwide across the United States.

Related recalls

Same category