VITROS 5600 Integrated System - Refurbished Software Versions 3.3.3 and below Product Code: 6802915 Unique Identifier: 10758750007110
Reported: July 8, 2020 Initiated: May 20, 2020 #Z-2483-2020
Product Description
VITROS 5600 Integrated System - Refurbished Software Versions 3.3.3 and below Product Code: 6802915 Unique Identifier: 10758750007110
Reason for Recall
Modifications to MicroWell Qualitative Assay Parameters Not Retained- may be inadvertently reset to default in certain circumstances
Details
- Recalling Firm
- Ortho Clinical Diagnostics
- Units Affected
- 130 units (U.S.=57; OUS=73)
- Distribution
- US Nationwide Distribution Foreign: Country AR AU BR CA CL CN CO DO FR ID IN JP KR MX MY NP PE PH SG TH TT VE VN
- Location
- Rochester, NY
Frequently Asked Questions
What product was recalled? ▼
VITROS 5600 Integrated System - Refurbished Software Versions 3.3.3 and below Product Code: 6802915 Unique Identifier: 10758750007110. Recalled by Ortho Clinical Diagnostics. Units affected: 130 units (U.S.=57; OUS=73).
Why was this product recalled? ▼
Modifications to MicroWell Qualitative Assay Parameters Not Retained- may be inadvertently reset to default in certain circumstances
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 8, 2020. Severity: Moderate. Recall number: Z-2483-2020.
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