Reported Apr 6, 2022 · Terminated
CARA (Computer Assisted Retinal Analysis), Product ID: +B543CARA0/$$+7V4.7.2/16D202111179
Diagnos Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Diagnos Inc · 7005 Taschereau Blvd Suite 265 · Brossard, N/A · N/A
Is this the product you have?
- CARA (Computer Assisted Retinal Analysis)
- Product ID+B543CARA0/$$+7V4.7.2/16D202111179
- Lot codes and dates
- Software Version 4.7.2
- Amount recalled
- 1
Where it was sold
Why it was recalled
Retinal analysis system software has some features, based on artificial intelligence, that potentially lack appropriate market approval, so it is recommended to use a specific prior software version.
This product could cause temporary or reversible health problems — stop using it.
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