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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device

Ortho Clinical Diagnostics: Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System

Agency Publication Date: August 6, 2019
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Affected Products

Product: VITROS 250 Chemistry System, clinical chemistry analyzer

product code: 8132086 UDI: 10758750004409 Affected software : Version 9.7

Lot Numbers:
8132086
Product: VITROS 250 Chemistry System, clinical chemistry analyzer

product code: 6801759 (Refurbished) UDI: 10758750001330 Affected software : Version 9.7

Lot Numbers:
6801759
Product: VITROS 250AT Chemistry System, clinical chemistry analyzer

product code: 1758143 UDI: 10758750000036 Affected software : Version 9.7

Lot Numbers:
1758143
Product: VITROS 350 Chemistry System, clinical chemistry analyzer

product code: 6802153 UDI: 10758750002054 Affected software : Version 9.7

Lot Numbers:
6802153
Product: VITROS Chemistry Products Calibrator Kit 32, for use with VITROS clinical chemistry analyzer

product code: 6844508 UDI: 10758750032105

Lot Numbers:
6844508
Product: VITROS 5600 Integrated System, clinical chemistry analyzer

product code: 6802413 UDI: 10758750002740 Affected software : Version 3.3.2 or above

Lot Numbers:
6802413
Product: VITROS 5600 Integrated System, clinical chemistry analyzer

product code: 6802915 UDI: 10758750007110 Affected software : Version 3.3.2 or above

Lot Numbers:
6802915
Product: VITROS 4600 Chemistry System, clinical chemistry analyzer

product code: 6802445 UDI: 10758750012343 Affected software : Version 3.3.2 or above

Lot Numbers:
6802445
Product: VITROS 4600 Chemistry System, clinical chemistry analyzer

product code: 6900440 UDI: 10758750033201 Affected software : Version 3.3.2 or above

Lot Numbers:
6900440
Product: VITROS 5,1 FS Chemistry System, clinical chemistry analyzer

product code: 6801375 UDI: 10758750001132 Affected software : Version 3.1 or above

Lot Numbers:
6801375
Product: VITROS 5,1 FS Chemistry System, clinical chemistry analyzer

product code:6801890 UDI: 10758750001644 Affected software : Version 3.1 or above

Lot Numbers:
6801890
Product: VITROS Chemistry Products Calibrator Kit 32, for use with VITROS clinical chemistry analyzer

product code:6844508 UDI: 10758750032105 Affected Assay Data Disk (ADD) DRV No: DRV 6032 or above

Lot Numbers:
6844508

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 83322
Status: Resolved
Manufacturer: Ortho Clinical Diagnostics
Manufactured In: United States
Units Affected: 10 products (30; 2; 30; 30; 2531; 89; 825; 9; 1051; 55)

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.