Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported June 24, 2020
VITROS Chemistry Product Performance Verifier II, Product Code 8067324, UDI # 10758750004317 - Product Usage: For in vitro diagnostic use only to quantitatively measure amylase activity in serum, plasma, and urine using VITROS 250/350/5, 1 FS/4600/XT 3400 Chemistry Systems and VITROS 5600/XT 7600 Integrated Systems.
Multiple coatings of VITROS Chemistry Products AMYL Slides are showing imprecision on control fluids when compared to the expected within lab SD as listed on the Performance Veri…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Ortho-Clinical Diagnostics recalled VITROS Chemistry Product Performance Verifier II, Product Code 8067324, UDI # 10758750004… - a moderate-severity action.
VITROS Chemistry Product Performance Verifier II, Product Code 8067324, UDI # 10758750004… was recalled by Ortho-Clinical Diagnostics in June 24, 2020. Reason: Multiple coatings of VITROS Chemistry Products AMYL Slides are showing imprecision on control fluids when co…. Check the official notice for the remedy. Verify recall #Z-2367-2020 with the FDA Devices before acting.
The recall
Ortho-Clinical Diagnostics issued this moderate-severity FDA Devices recall-Multiple coatings of VITROS Chemistry Products AMYL Slides are showing imprecision on control fluids when co….
- Moderate
- severity level
- Class II
- classification
- June 24, 2020
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2367-2020 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-2367-2020) was formally reported on June 24, 2020, with the manufacturer initiating the action on May 11, 2020. It is classified under Moderate severity (Class II), with a current status of Terminated. Ortho-Clinical Diagnostics is listed as the recalling firm, operating out of Rochester, NY. The number of affected units is not disclosed in the agency filing, which is common for drug and food recalls where lot-level tracking supersedes unit counts.
The documented reason for this recall is: Multiple coatings of VITROS Chemistry Products AMYL Slides are showing imprecision on control fluids when compared to the expected within lab SD as listed on the Performance Verifier (PV) Assay Sheets. Distribution data in the federal record shows the product reached: Worldwide distribution - US Nationwide including in the statesof Maine, Massachusetts, Vermont, Connecticut, New Jersey, New York, Pennsylvania, Washington DC, Maryland, Virginia, West Virginia, North Carolina, South Ca…. 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 - 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 - 40,422 medical devices recalls on record
Where this recall sits in the database
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
Unknown
Related Recalls
6
0 from same agency
Product description
VITROS Chemistry Product Performance Verifier II, Product Code 8067324, UDI # 10758750004317 - Product Usage: For in vitro diagnostic use only to quantitatively measure amylase activity in serum, plasma, and urine using VITROS 250/350/5, 1 FS/4600/XT 3400 Chemistry Systems and VITROS 5600/XT 7600 Integrated Systems.
Reason for recall
Multiple coatings of VITROS Chemistry Products AMYL Slides are showing imprecision on control fluids when compared to the expected within lab SD as listed on the Performance Verifier (PV) Assay Sheets.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2367-2020 |
| Date reported | June 24, 2020 |
| Date initiated | May 11, 2020 |
| Recalling firm | Ortho-Clinical Diagnostics |
| Firm location | Rochester, NY |
| Affected scope | Not disclosed |
| Distribution | Worldwide distribution - US Nationwide including in the statesof Maine, Massachusetts, Vermont, Connecticut, New Jersey, New York, Pennsylvania, Washington DC, Maryland, Virginia, West Virginia, North Carolina, South Carolina, Georgia, Flo… |
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-2367-2020) 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 Chemistry Product Performance Verifier II, Product Code 8067324, UDI # 10758750004317 - Product Usage: For in vitro diagnostic use only to quantitatively measure amylase activity in serum, plasma, and urine using VITROS 250/350/5, 1 FS/4600/XT 3400 Chemistry Systems and VITROS 5600/XT 7600 Integrated Systems.. Recalled by Ortho-Clinical Diagnostics.
Why was this product recalled? ▼
Multiple coatings of VITROS Chemistry Products AMYL Slides are showing imprecision on control fluids when compared to the expected within lab SD as listed on the Performance Verifier (PV) Assay Sheets.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 24, 2020. Severity: Moderate. Recall number: Z-2367-2020.
Where was the recalled product distributed? ▼
Distribution: Worldwide distribution - US Nationwide including in the statesof Maine, Massachusetts, Vermont, Connecticut, New Jersey, New York, Pennsylvania, Washington DC, Maryland, Virginia, West Virginia, North Carolina, South Carolina, Georgia, Florida, Alabama, Tennessee, Missouri, Mississippi, Kentucky, Ohio, Indiana, Michigan, Iowa, Wisconsin, Minnesota, South Dakota, North Dakota, Montana, Illinois, Kansas, Nebraska, Louisiana, Arkansas, Oklahoma, Texas, Colorado, Idaho, Utah, Arizona, New Mexico, California, Hawaii, Oregon , Washington, and Alaska.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-2367-2020) 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.
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Data Sources
Source: FDA, CPSC, and NHTSA federal recall databases. This recall: FDA Devices, reported June 24, 2020.
- Source: FDA - Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
- Source: CPSC - Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
- Source: NHTSA - National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)
Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. 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.