Sight OLO-E1/U1 Software and Operators Manual Software recall: Software Issue
Sight OLO-E1/U1 Software and Operators Manual Software v2.56.1 Catalog #: 1 OLO-U1 Catalog #: 2 OLO-E1 revision 1.9, revision 1.10
Why was Sight OLO-E1/U1 Software and Operators Manual Software recalled?
Discrepancy in labeling between the adult CBC reference ranges presented in the OLO Operator's Manual and the OLO software
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Software v2.56.1 Catalog #: 1 OLO-U1 Catalog #: 2 OLO-E1 revision 1.9, revision 1.10
- Product
- Sight OLO-E1/U1 Software and Operators Manual Software v2.56.1 Catalog #: 1 OLO-U1 Catalog #: 2 OLO-E1 revision 1.9, revision 1.10
- Recalling firm
- SIGHT DIAGNOSTICS LTD
- Quantity
- 114 units
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of Alabama, Florida, Massachusetts, Minnesota, Missouri, New York, Ohio, Texas, Virginia, Washington and the countries of AUSTRALIA, CHILE, UNITED KINGDOM, GEORGIA, ISRAEL, Mexico, NETHERLANDS, Portugal, Russia, Singapore, Thailand.
- Recall date
- September 29, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)