Z-2177-2019Class II
VITROS 350 Chemistry System, clinical chemistry analyzer
Ortho-Clinical Diagnostics, Inc. / initiated 2019-07-08 / Terminated / root cause: software
Ortho Clinical Diagnostics began a recall of VITROS 350 Chemistry System, clinical chemistry analyzer on . FDA classified it as Class II and gives the reason as "Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System". As of , the recall status on record is Terminated, and MDM tags the root cause as software.
Recall record
- Recall number
- Z-2177-2019
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Ortho-Clinical Diagnostics, Inc.
- Product
- VITROS 350 Chemistry System, clinical chemistry analyzer
- Product code
- JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
- Reason for recall
- Potential Unsuccessful Calibration Due to Software Anomaly in VITROS System
- Root cause tag
- software
- FDA root cause
- Software design
- Action
- Customers were notified prior to July 10, 2019. For the VITROS 250, 250AT, and 350 chemistry system: Do not use VITROS Calibrator Kit 32 to calibrate assays until an Ortho trained service personnel reconfigures your system(s) with the correct parameters for VITROS Calibrator Kit 32. Complete the enclosed Confirmation of Receipt form no later than July 15, 2019. Post this notification by each system that may use VITROS Calibrator Kit 32 until your system is reconfigured by an Ortho trained representative. Please forward this notification if the product was distributed outside of your facility. For the VITROS 4600,5600 and 5,1 FS chemistry System: If your system is configured with User Modified parameters, choose an option provided in the Interim Resolutions section listed above. Install ADD DRV 6040 or above upon availability. Complete the enclosed Confirmation of Receipt form no later than July 15, 2019. Post this notification either by each system that processes VITROS Calibrator Kit 32 or with your user documentation until DRV 6040 or above is installed on your system(s). Please forward this notification if the product was distributed outside of your facility. If you have further questions, please contact Ortho Care Technical Solutions Center at 1-800-421-3311.
- Quantity in commerce
- 30
- Distribution
- Worldwide distribution. US nationwide including Puerto Rico, Brazil, Canada, Chile, France, India, and Philippines.
- Product codes and lots
- product code: 6802153 UDI: 10758750002054 Affected software : Version 9.7
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-2174-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2175-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2176-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2177-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2178-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2179-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2180-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2181-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2182-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2183-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2184-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2185-2019 | Class II | Terminated | Voluntary: Firm initiated |
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