Recall Z-0963-2022
Sight Diagnostics Ltd · initiated January 20, 2022
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: 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/$$+7Q-384U Q387 +B787OLOU10/$$+7Q-387X Q391 +B787OLOU10/$$+7Q-391S Q393 +B787OLOU10/$$+7Q-393U Q394 +B787OLOU10/$$+7Q-394V Q398 +B787OLOU10/$$+7Q-398Z Q400 +B787OLOU10/$$+7Q-400J Q403 +B787OLOU10/$$+7Q-403M Q411…
Reason for recall
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
FDA-determined cause: Software design
Action taken
Sight Diagnostics issued Medical Device Recall Notification on 1/20/22 via email to Distributors and End Users. Letter states reason for recall, health risk and action to take: In case you have configured your own reference ranges, please review the configured values to ensure all values are set properly. You can then continue to use your OLO analyzer. The software version of the OLO analyzer in your possession will be updated to a new version that resolves this software defect. The update will be performed remotely by Sights product specialists, who will contact you to schedule the update. Please be aware that the software version update requires the analyzer to be connected to the internet. If you need to make any adjustments to your reference ranges before the software update is performed, please avoid pressing the Cancel button while editing a reference range parameter, and always review all parameters after making any changes, to confirm values are set properly. If you are a distributor, please share this recall notification letter with any customer to whom the product was shipped, or may have been shipped. You are kindly requested to fill the attached Acknowledgement and Receipt Form, and return it to notifications@sightdx.com within 30 days. Software version 2.63 was released and includes the fix for the software defect mentioned above. Questions please contact us at Support@sightdx.com. For full indications for use and safety information please refer to the Quality and Compliance page at www.sightdx.com.
Details
- Recall number
- Z-0963-2022
- Initiated
- January 20, 2022
- Product code
- GKZ – Counter, Differential Cell
- Quantity
- 322 units: U.S 109 Foreign 213
- Distribution
- Worldwide distribution - US Nationwide and the countries of AUSTRALIA, CANADA, CHILE, CURACAO, FINLAND, GEORGIA, GERMANY, GREECE, HONG KONG, IRELAND, ISRAEL, ITALY, MEXICO, NETHERLANDS, PORTUGAL, SINGAPORE, SLOVENIA, UNITED ARAB EMIRATES, UNITED KINGDOM.
- Recalling firm
- Sight Diagnostics Ltd, Tel Aviv-Yafo