Reported Sep 14, 2022 · Ongoing
VITROS XT 7600 Integrated System with Version 3.7.2 and below Product Code: 6844461
Ortho-Clinical Diagnostics, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Ortho-Clinical Diagnostics, Inc. · 100 Indigo Creek Dr · Rochester, NY · 14626-5101
Is this the product you have?
- VITROS XT 7600 Integrated System with Version 3.7.2
- and below Product Code6844461
- Lot codes and dates
- UDI-DI10758750031610 Systems start with 7600XXXX where XXXX is unique for each analyzer
- Amount recalled
- 1148 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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