Ortho-Clinical Diagnostics, Inc: VITROS Immunodiagnostic Products Prolactin Reagent Pack Product Code: 1849793

Recall number

Z-1114-2022

Recalling firm

Ortho-Clinical Diagnostics, Inc

Product

VITROS Immunodiagnostic Products Prolactin Reagent Pack Product Code: 1849793

Status

Open, Classified

Initiated

2022-03-25

Posted

not on file

Terminated

not on file

Reason

Falsely high or delayed patient and QC results may occur due to low end imprecision. VITROS Immunodiagnostic Products FSH, LH and Prol Reagents Low End Imprecision. Low-level quality control (QC) and patient samples at the low end of the Measuring (Reportable) Range when using VITROS FSH, LH and Prol Reagent. Calibration failures, driven by imprecision observed with Calibrator Level 1.

Root cause

Device Design

Action

Ortho CLinical Diagnostics issued "URGENT PRODUCT CORRECTION NOTIFICATION" dated 3/25/22 to consignees who had been shipped VITROS FSH, LH or Prol in the previous 18 months were notified (CL2022-069) of the issue and instructed as follows: -Run daily low-level QC in duplicate to confirm acceptable performance. -If their laboratory is experiencing low end imprecision with VITROS FSH, LH or Prol Reagent, follow one of the suggested testing algorithms as described in the enclosure. o Note: If their laboratory is not experiencing low end imprecision, continue testing patient samples as usual (single replicate). -Until further notice, all future lots of the products will also be affected. -On the enclosed Credit Form, track the additional quantities of VITROS FSH, LH and/or Prol tests used due to the testing protocol. Periodically submit the form to Ortho. Ortho will credit their account. If you have further questions, please contact Ortho Care Technical Solutions Center at 1-800-421-3311.

Quantity

1767 units total: 1521 US; 246 OUS

Distribution

Worldwide Distribution: US (Nationwide) OUS (Foreign): Australia Bermuda Brazil Canada L3R 4G5 Chile China Colombia Denmark France Germany India Italy Japan Mexico Netherlands Norway Portugal Russia Singapore Spain Sweden United Kingdom

Lot, serial or model codes

Until further notice, future lots will also be affected. UDI: 10758750000111 Affected Lot Number/ Expiration Date: 2840 13-MAY-2022; 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;

510(k) numbers

["K970281"]

PMA numbers

not on file

Product code

CFT

Firm FEI

2250051

Firm city

Raritan

Firm state

NJ

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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