Lower riskMedical device recall · FDA · Published March 25, 2022
Ortho-Clinical VITROS LH Reagent Pack: False High Results Risk
Ortho-Clinical recalls VITROS LH Reagent Packs (lot 1910-1960) due to potential false high or delayed test results. Affected units may cause inaccurate patient and QC results.
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.
“Ortho-Clinical VITROS LH Reagent Pack: False High Results Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/60890-ortho-clinical-vitros-lh-reagent-pack-false-high-results-risk. Based on FDA recall #Z-1113-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1113-2022%22&limit=1).
The FDA announced on March 25, 2022, that Ortho-Clinical Diagnostics, Inc. is recalling VITROS Immunodiagnostic Products LH Reagent Pack (Product Code: 1350198). The recall addresses the hazard of falsely high or delayed patient and quality control results due to low end imprecision.
Distribution: Worldwide including US, Australia, Bermuda, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Netherlands, Norway, Portugal, Russia, Singapore, Spain, Sweden, United Kingdom
The hazard
Falsely high or delayed patient and quality control results may occur due to low end imprecision. This issue affects VITROS Immunodiagnostic Products FSH, LH and Prol Reagents at the low end of the Measuring Range. Calibration failures are driven by imprecision observed with Calibrator Level 1.
Context
GovInfoNow's records show Ortho-Clinical Diagnostics, Inc. has 53 other recalls on record since July 10, 2017. Other recent recalls of similar products include Ortho-Clinical LAC Slides Recall (July 29, 2025), Ortho-Clinical VITROS Ca Slides Recall (July 9, 2025), and Ortho-Clinical VITROS OP Reagent Gen 15 May Cause Inaccurate Test Results (June 12, 2025). Other recent recalls of similar products include LH One Step Ovulation Test Device Recall (Nov. 22, 2025), Tosoh ST AIA-Pack Testosterone Recall (June 12, 2026), and Vivoo Vaginal pH Test Recall (Nov. 22, 2025).
How to tell if you have this one
Check for product code 1350198 on the reagent pack. Affected lots were sold from August 2022 through January 2023 with expiration dates listed as 1910-1960.
Brand
Ortho-Clinical
Category
Medical device
FDA recall event · 3 products
All 3 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Ongoing
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
Recall number
Product, codes & lots
Quantity
Z-1112-2022
VITROS Immunodiagnostic Products FSH Reagent Pack- IVD 1931922; Until further notice, future lots will also be affected. UDI: 10758750000302 Affected Lot Number/ Expiration Date: 3100 01-MAR-2022; 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.
2502 total: 2154 US; 348 OUS
Z-1113-2022
VITROS Immunodiagnostic Products LH Reagent Pack Product Code: 1350198; 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
1575 units total: 1183 US; 392 OUS
Z-1114-2022
VITROS Immunodiagnostic Products Prolactin Reagent Pack Product Code: 1849793; 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;
1767 units total: 1521 US; 246 OUS
Based on the official FDA remedy
What to do — step by step
Check Reagent Lot Number
Look for the lot number on the reagent pack to see if it matches the affected lots (1910-1960).
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA 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” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 2 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
This recall is for potential inaccurate test results, not immediate safety risks. The hazard is low risk as it affects test accuracy rather than causing injury.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1113-2022 (March 25, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1113-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.