VITROS XT 7600 Integrated System with Version 3.7.2 and below Product Code: 6844461
Reported: September 14, 2022 Initiated: July 19, 2022 #Z-1676-2022
Product Description
VITROS XT 7600 Integrated System with Version 3.7.2 and below Product Code: 6844461
Reason for Recall
Performing a system shutdown on VITROS XT 3400 and VITROS XT 7600 Systems may cause a positive or negative shift in the electrical current supplied to the LED used in conjunction with the Digital Imaging Reflectometer. Potential exists for either a positive or negative shift in results reported by the VITROS System.
Details
- Recalling Firm
- Ortho-Clinical Diagnostics, Inc.
- Units Affected
- 1148 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of Australia, Belgium, Bermuda DV04, Brazil, Canada L3R 4G5 , Chile, China, Colombia, Denmark, France, France, Germany, India, Italy, Japan, Mexico, Norway, Portugal, Russia, Singapore 609917, Spain, Sweden, The Netherlands, United Kingdom.
- Location
- Rochester, NY
Frequently Asked Questions
What product was recalled? ▼
VITROS XT 7600 Integrated System with Version 3.7.2 and below Product Code: 6844461. Recalled by Ortho-Clinical Diagnostics, Inc.. Units affected: 1148 units.
Why was this product recalled? ▼
Performing a system shutdown on VITROS XT 3400 and VITROS XT 7600 Systems may cause a positive or negative shift in the electrical current supplied to the LED used in conjunction with the Digital Imaging Reflectometer. Potential exists for either a positive or negative shift in results reported by the VITROS System.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on September 14, 2022. Severity: Moderate. Recall number: Z-1676-2022.
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