Z-2517-2021Class II

Sight OLO-E1/U1 Software and Operators Manual Software v2.56.1 Catalog #: 1 OLO-U1 Catalog #: 2 OLO-E1...

Name: Z-2517-2021 Sight OLO-E1/U1 Software and Operators Manual Software v2.56.1 Catalog #: 1 OLO-U1 Catalog #: 2 OLO-E1...
Creator: Sight Diagnostics Ltd
Published: 2021-03-17
License: https://open.fda.gov/license/

Sight Diagnostics, Ltd. / initiated 2021-03-17 / Terminated / root cause: labeling and UDI

FDA source

SIGHT DIAGNOSTICS LTD began a recall of 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 on 2021-03-17. FDA classified it as Class II and gives the reason as "Discrepancy in labeling between the adult CBC reference ranges presented in the OLO Operator's Manual and the OLO software". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2517-2021
Classification: Class II
Status: Terminated
Initiated: 2021-03-17
Posted: 2021-09-22
Terminated: 2022-06-08
Recalling firm: Sight Diagnostics, Ltd.
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
Product code: GKZ Counter, Differential Cell
Reason for recall: Discrepancy in labeling between the adult CBC reference ranges presented in the OLO Operator's Manual and the OLO software
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: Sight Diagnosics issued URGENT 2021-03-16 Medical Device Recall Notification on 3/15/21 via email. Letter states reason for recall, health risk and action to take: Corrective and Preventive Actions Taken by the Company: Section 5.7.1 of both OLO-E1 and OLO-U1 Operator s Manuals has been updated to reflect the adult reference ranges verified by Sight. Software version v2.56.1 was updated to software version v2.56.2, which is configured (by default) with the adult reference ranges verified by Sight. Actions to be taken by the customer: Please discard all previous Operator's Manuals in your possession. Attached to this recall notification is the OLO Operators Manual, rev. 1.14 (U1) and 1.15 (E1). The updated Operator's Manual includes Sights verified reference ranges. Each laboratory should either validate these ranges or establish their own in accordance with their state and regulatory agency guidelines. The software version of the OLO analyzer in your possession will be updated to a new version that includes the above mentioned correction. The update will be performed remotely by Sight's product specialists, who will contact you in the coming month to schedule the update. Please be aware that the software version update requires the analyzer to be connected to the internet. If you are a distributor, please provide a copy of this recall notification and updated Operator s Manual to any customer whom the product was shipped to, or may have been shipped to. If you have been authorised by Sight to translate the Operator s Manual, please make sure you update the Operator s Manual s translation accordingly. You are kindly requested to fill the attached Acknowledgement and Receipt Form, and return it to Sight [email protected] within 30 days. If you are required to notify your local authority, please use this notification letter and inform Sight as soon as possible. If you have any questions please contact us at [email protected]. For full indicati
Quantity in commerce: 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.
Product codes and lots: Software v2.56.1 Catalog #: 1 OLO-U1 Catalog #: 2 OLO-E1 revision 1.9, revision 1.10

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2517-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2517-2021	Class II	Terminated	Voluntary: Firm initiated	2021-09-29	2021-09-22

Product code GKZ

K190898Class IISight OLOSight Diagnostics , Ltd. / cleared 2019-11-01

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)