VITROS 5,1 FS Chemistry System, clinical chemistry analyzer
Reported: August 14, 2019 Initiated: July 8, 2019 #Z-2184-2019
Product Description
VITROS 5,1 FS Chemistry System, clinical chemistry analyzer
Reason for Recall
Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System
Details
- Recalling Firm
- Ortho Clinical Diagnostics
- Units Affected
- 55
- Distribution
- Worldwide distribution. US nationwide including Puerto Rico, Brazil, Canada, Chile, France, India, and Philippines.
- Location
- Rochester, NY
Frequently Asked Questions
What product was recalled? ▼
VITROS 5,1 FS Chemistry System, clinical chemistry analyzer. Recalled by Ortho Clinical Diagnostics. Units affected: 55.
Why was this product recalled? ▼
Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 14, 2019. Severity: Moderate. Recall number: Z-2184-2019.
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