Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported May 25, 2022
VITROS Immunodiagnostic Products LH Reagent Pack Product Code: 1350198
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…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Ortho-Clinical Diagnostics, Inc recalled VITROS Immunodiagnostic Products LH Reagent Pack Product Code: 1350198 - a moderate-severity action.
VITROS Immunodiagnostic Products LH Reagent Pack Product Code: 1350198 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-1113-2022 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
- 2K units
- affected scope
- Class II
- classification
- May 25, 2022
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1113-2022 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1113-2022) was formally reported on May 25, 2022, with the manufacturer initiating the action on March 25, 2022. It is classified under Moderate severity (Class II), with a current status of Ongoing. Ortho-Clinical Diagnostics, Inc is listed as the recalling firm, operating out of Raritan, NJ. Federal records list the affected scope as 1575 units total: 1183 US; 392 OUS.
The documented reason for this recall is: 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 … Distribution data in the federal record shows the product reached: 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 Sw…. Distribution scope 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, 3 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 - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. 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.
Affected scope
1575 units total: 1183 US; 392 OUS
Related Recalls
6
3 from same agency
Product description
VITROS Immunodiagnostic Products LH Reagent Pack Product Code: 1350198
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-1113-2022 |
| Date reported | May 25, 2022 |
| Date initiated | March 25, 2022 |
| Recalling firm | Ortho-Clinical Diagnostics, Inc |
| Firm location | Raritan, NJ |
| Affected scope | 1575 units total: 1183 US; 392 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-1113-2022) 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.
Frequently Asked Questions
What product was recalled? ▼
VITROS Immunodiagnostic Products LH Reagent Pack Product Code: 1350198. Recalled by Ortho-Clinical Diagnostics, Inc. Units affected: 1575 units total: 1183 US; 392 OUS.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 25, 2022. Severity: Moderate. Recall number: Z-1113-2022.
Where was the recalled product distributed? ▼
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.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1113-2022) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
Nearby Recalls in This Category
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported May 25, 2022. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.