Sight OLO-E1/U1 Software and Operators Manual Software v2.56.1 Catalog #: 1 OLO-U1 Catalog #: 2 OLO-E1 revision 1.
Summary
The FDA issued a Class II for Sight OLO-E1/U1 Software and Operators Manual Software v2.56.1 Catalog #: 1 OL by SIGHT DIAGNOSTICS LTD. Reason: Discrepancy in labeling between the adult CBC reference ranges presented in the OLO Operator's Manual and the OLO software.
Details
Source
Device Recall
External ID
Z-2517-2021
Action Date
2021-09-29
Status
Terminated
Category
device
Product Description
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
Lot/Code Info: Software v2.56.1 Catalog #: 1 OLO-U1 Catalog #: 2 OLO-E1 revision 1.9, revision 1.10
Quantity Affected: 114 units
Reason for Recall
Discrepancy in labeling between the adult CBC reference ranges presented in the OLO Operator's Manual and the OLO software
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-03-17
Company
Tel Aviv-Yafo
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 173 device recalls issued in the same week, part of 403 device-related FDA actions this month.
SIGHT DIAGNOSTICS LTD has 4 FDA actions in our database, including 4 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (SIGHT DIAGNOSTICS LTD) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does SIGHT DIAGNOSTICS LTD have FDA actions?
SIGHT DIAGNOSTICS LTD has 4 FDA actions in our database, including 4 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2517-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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