Recall Z-2517-2021— SIGHT DIAGNOSTICS LTD
Class II · Terminated
Class II FDA medical device recall by SIGHT DIAGNOSTICS LTD, initiated 2021-03-17, terminated 2022-06-08. It names one FDA 510(k) clearance: K190898. 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. Reason: Discrepancy in labeling between the adult CBC reference ranges presented in the OLO Operator's Manual and the OLO software.
- Recalling firm
- SIGHT DIAGNOSTICS LTD
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-03-17
- Terminated
- 2022-06-08
- Firm location
- Tel Aviv-Yafo, Israel
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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
Reason for recall
Discrepancy in labeling between the adult CBC reference ranges presented in the OLO Operator's Manual and the OLO software
Data sourced from openFDA. This site is unofficial and independent of the FDA.