SIGHT DIAGNOSTICS LTD: Medical Device Recall in 2021 - (Recall #: Z-2517-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

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

Product Classification:

Class II

Date Initiated: March 17, 2021

Date Posted: September 29, 2021

Recall Number: Z-2517-2021

Event ID: 88401

Reason for Recall:

Discrepancy in labeling between the adult CBC reference ranges presented in the OLO Operator's Manual and the OLO software

Status: Terminated

Product Quantity: 114 units

Code Information:

Software v2.56.1 Catalog #: 1 OLO-U1 Catalog #: 2 OLO-E1 revision 1.9, revision 1.10

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated