FDA Devices recall · Reported May 25, 2022
VITROS Immunodiagnostic Products FSH Reagent Pack- IVD 1931922
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 qual…
Ortho-Clinical Diagnostics, Inc recalled VITROS Immunodiagnostic Products FSH Reagent Pack- IVD 1931922 - a moderate-severity action.
VITROS Immunodiagnostic Products FSH Reagent Pack- IVD 1931922 was recalled by Ortho-Clinical Diagnostics, Inc in May 25, 2022. Reason: Falsely high or delayed patient and QC results may occur due to low end imprecision. VITROS Immunodiagnostic …. Check the official notice for the remedy. Verify recall #Z-1112-2022 with the FDA Devices before acting.
The recall
Ortho-Clinical Diagnostics, Inc issued this moderate-severity FDA Devices recall-Falsely high or delayed patient and QC results may occur due to low end imprecision. VITROS Immunodiagnostic ….
- Moderate
- severity level
- Class II
- classification
- May 25, 2022
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1112-2022 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 41,021 medical devices recalls on record
Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Product description
VITROS Immunodiagnostic Products FSH Reagent Pack- IVD 1931922
Reason for recall
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-1112-2022 |
| Date reported | May 25, 2022 |
| Date initiated | March 25, 2022 |
| Recalling firm | Ortho-Clinical Diagnostics, Inc |
| Firm location | Raritan, NJ |
| Affected scope | 2502 total: 2154 US; 348 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 |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1112-2022) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Nationwide recalls with similar severity or category timing
Drug and device notices outside this firm and state, matched by severity timing and product category.
Similar severity · nearest report date
Same archive severity grade (Moderate), closest by report date among other firms and states.
Similar Medical Devices · nearest report date
Same product category, closest by report date among other firms and states (deduped against the severity set).
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Methodology · Corrections · Archive as of August 2026