The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1114-2022·Announced 2022-05-25

VITROS Prolactin Reagent Recalled for Low-End Measurement Imprecision

Ortho-Clinical Diagnostics is recalling VITROS Prolactin Reagent packs due to low-end measurement imprecision that may cause falsely high or delayed test results. Approximately 1,767 affected units are distributed worldwide.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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 recall with no reported injuries or illnesses. Measurement imprecision qualifies as a risk-of-harm product, as inaccurate prolactin test results could lead to misdiagnosis. Per rubric, such products without reported injury score as High.

Plain-English summary

Ortho-Clinical Diagnostics, Inc. is recalling VITROS Immunodiagnostic Products Prolactin Reagent Pack (Product Code: 1849793). The recall affects 1,767 units distributed worldwide, including 1,521 units in the United States and 246 units internationally to countries including Australia, Brazil, Canada, China, Japan, and others.

The recalled reagent packs exhibit low-end measurement imprecision that can produce falsely high or delayed patient test results and quality control results. Calibration failures resulting from imprecision in Calibrator Level 1 impact samples at the lower end of the measuring range.

Affected lot numbers are 2840, 2850, 2860, 2870, 2875, 2880, 2891, and 2900, with expiration dates ranging from May 13, 2022, through October 29, 2022. The FDA indicates that future lots will also be affected until further notice.

Healthcare facilities and laboratories using affected lot numbers should discontinue use immediately. Contact the manufacturer for replacement product or additional information.

The recalled product

Product
VITROS Immunodiagnostic Products Prolactin Reagent Pack Product Code: 1849793
Manufacturer
Ortho-Clinical Diagnostics, Inc
Category
Medical Device — Immunodiagnostic Reagent
Hazard

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 (8)

  • Until further notice
  • 2850 08-JUN-2022
  • 2860 02-JUL-2022
  • 2870 17-JUL-2022
  • 2875 17-JUL-2022
  • 2880 14-SEP-2022
  • 2891 28-SEP-2022
  • 2900 29-OCT-2022

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 recalled by Ortho-Clinical Diagnostics, Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

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