Z-1373-2024 Class II Ongoing
FDA device recall Z-1373-2024 was initiated by Ortho-Clinical Diagnostics on Feb 27, 2024 and is designated Class II. Reason for recall: The issue was mismatched diluent lots assembled into VITRO Chemistry Products Performance Verifier I and II. This issue has the potential to cause erroneous Quality Control (QC) results that could… The recall status is ongoing. Affected quantity: 11,224 units.
Recall Details
- Product Type
- Devices
- Report Date
- Apr 3, 2024
- Initiation Date
- Feb 27, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 11,224 units
Product Description
VITROS Performance Verifier II
Reason for Recall
The issue was mismatched diluent lots assembled into VITRO Chemistry Products Performance Verifier I and II. This issue has the potential to cause erroneous Quality Control (QC) results that could lead to testing delays and erroneous patient results. This issue caused positive or negative bias in the quantification of sodium (Na+) and total carbon dioxide (ECO2). The incorrect diluent into the Performance Verifier II exhibited a potential negative bias of up to 6 mmol/L for ECO2 and Na+ testing.
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of Australia, Belgium, Bermuda, Brazil, Canada, Chile, China, Colombia, Denmark, France, Germany, India, Italy, Japan, Mexico, Norway, Portugal, Russia, Singapore, Spain, Sweden, The Netherlands, United Kingdom.
Code Information
Product Code: 8231474; GTIN: 10758750004577; Lot No. R1176.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1373-2024
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026