VITROS Immunodiagnostic Products LH Reagent Pack recallZ-1113-2022 · Ortho-Clinical Diagnostics, Inc · initiated Mar 25, 2022
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Ortho-Clinical Diagnostics, Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Device Design
What the company is doing
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.
Recall details
- Recall number
- Z-1113-2022
- Status
- Open, Classified
- Initiated by the company
- Mar 25, 2022
- Recalling firm
- Ortho-Clinical Diagnostics, Inc
- Quantity
- 1575 units total: 1183 US; 392 OUS
- Product code
- CEP
- FDA submissions
- K964982
- 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
Product description
VITROS Immunodiagnostic Products LH Reagent Pack Product Code: 1350198
Code information (models, lots, serial numbers)
Until further notice, future lots will also be affected. UDI: 10758750008902 Affected Lot Number/ Expiration Date: 1910 14-AUG-2022 1920 19-SEP-2022 1930 19-OCT-2022 1940 31-OCT-2022 1950 28-JAN-2023 1960 31-JAN-2023
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- VITROS 1350198Ortho Clinical Diagnostics · RADIOIMMUNOASSAY, LUTEINIZING HORMONE1 recall0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 90047).
- Z-1112-2022 · Open, ClassifiedVITROS Immunodiagnostic Products FSH Reagent Pack- IVD 1931922
- Z-1114-2022 · Open, ClassifiedVITROS Immunodiagnostic Products Prolactin Reagent Pack Product Code: 1849793
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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