FDA Device recall Z-0963-2022
The Sight OLO device is a computer vision based platform for blood analysis
- FDA Device
- Class II
- ongoing
- Published 2022-04-27
On 2022-04-27 the FDA classified a Class II recall of The Sight OLO device is a computer vision based platform for blood analysis by Sight Diagnostics, citing in instances where custom reference ranges were configured on the device post installation, a possibility to inadvertently apply changes to reference range values was found on sof….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0963-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-01-20 |
| Published | 2022-04-27 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Sight Diagnostics |
| Distribution | US |
Product
The Sight OLO device is a computer vision based platform for blood analysis. The platform combines computer-vision algorithms for image processing to identify and quantify blood components (e.g., red blood cells) and their characteristics (e.g., cell volume) in an automated fashion. Using dedicated staining, the proposed platform provides complete blood count analysis. The Sight OLO is a compact device, designed to be automated and simple to operate, to enable rapid testing and analysis. The Sight OLO consists of a scanning and analyzing device and a CBC test kit, including disposable cartridges and sample preparation tools. The disposable cartridge containing the blood sample is loaded into the device through the loading slot. The device is operated through the touch screen interface. The Sight OLO provides complete blood count information with 5-part differentials for white blood cell types. Specifically, the CBC parameters measured by the Sight OLO are listed below and include: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW, PLT, NEUT%/#, LYMPH %/#, MONO %/#, EO%/# and BASO%/#. In addition, the Sight OLO signals specific WBC abnormal cases by flagging the sample.
Reason
In instances where custom reference ranges were configured on the device post installation, a possibility to inadvertently apply changes to reference range values was found on software versions 2.59.3 and all earlier versions, which can potentially lead to displaying and printing incorrectly-configured reference range values
Identifiers
| code_info | Software versions up to and including v2.59.3. Serial Number UDI (US): Q100 +B787OLOU10/$$+7Q-100G Q121 +B787OLOU10/$…Software versions up to and including v2.59.3. Serial Number UDI (US): Q100 +B787OLOU10/$$+7Q-100G Q121 +B787OLOU10/$$+7Q-121J Q138 +B787OLOU10/$$+7Q-138R Q145 +B787OLOU10/$$+7Q-145P Q146 +B787OLOU10/$$+7Q-146Q Q167 +B787OLOU10/$$+7Q-167T Q212 +B787OLOU10/$$+7Q-212K Q213 +B787OLOU10/$$+7Q-213L Q225 +B787OLOU10/$$+7Q-225O Q228 +B787OLOU10/$$+7Q-228R Q241 +B787OLOU10/$$+7Q-241M Q258 +B787OLOU10/$$+7Q-258U Q264 +B787OLOU10/$$+7Q-264R Q270 +B787OLOU10/$$+7Q-270O Q273 +B787OLOU10/$$+7Q-273R Q275 +B787OLOU10/$$+7Q-275T Q277 +B787OLOU10/$$+7Q-277V Q283 +B787OLOU10/$$+7Q-283S Q303 +B787OLOU10/$$+7Q-303L Q331 +B787OLOU10/$$+7Q-331M Q332 +B787OLOU10/$$+7Q-332N Q334 +B787OLOU10/$$+7Q-334P Q338 +B787OLOU10/$$+7Q-338T Q341 +B787OLOU10/$$+7Q-341N Q347 +B787OLOU10/$$+7Q-347T Q352 +B787OLOU10/$$+7Q-352P Q363 +B787OLOU10/$$+7Q-363R Q365 +B787OLOU10/$$+7Q-365T Q372 +B787OLOU10/$$+7Q-372R Q375 +B787OLOU10/$$+7Q-375U Q380 +B787OLOU10/$$+7Q-380Q Q383 +B787OLOU10/$$+7Q-383T Q384 +B787OLOU10/$$+7Q-384U Q38 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0963-2022%22
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