The Sight OLO device is a computer vision based platform for blood analysis
Medical device recall Z-0963-2022. Published in FDA’s Enforcement Report on Apr 27, 2022.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Apr 27, 2022. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 322 units: U.S 109 Foreign 213 how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
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.
322 units: U.S 109 Foreign 213, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
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…
Every code shown here, 1,980 characters
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 +B787OLOU10/$$+7Q-411L Q417 +B787OLOU10/$$+7Q-417R Q418 +B787OLOU10/$$+7Q-418S Q420 +B787OLOU10/$$+7Q-420L Q424 +B787OLOU10/$$+7Q-424P Q427 +B787OLOU10/$$+7Q-427S Q436 +B787OLOU10/$$+7Q-436S Q437 +B787OLOU10/$$+7Q-437T Q440 +B787OLOU10/$$+7Q-440N Q442 +B787OLOU10/$$+7Q-442P Q451 +B787OLOU10/$$+7Q-451P Q452 +B787OLOU10/$$+7Q-452Q Q462 +B787OLOU10/$$+7Q-462R Q463 +B787OLOU10/$$+7Q-463S Q465 +B787OLOU10/$$+7Q-465U Q467 +B787OLOU10/$$+7Q-467W Q468 +B787OLOU10/$$+7Q-468X Q469 +B787OLOU10/$$+7Q-469Y Q470 +B787OLOU10/$$+7Q-470Q Q472 +B787OLOU10/$$+7Q-472S Q489 +B787OLOU10/$$+7Q-489- Q496 +B787OLOU10/$$+7Q-496Y Q499 +B787OLOU10/$$+7Q-499. Q510 +B787OLOU10/$$+7Q-510L Q511 +B787OLOU10/$$+7Q-511M Q512 +B787OLOU10/$$+7Q-512N Q513 +B787OLOU10/$$+7Q-513O Q515 +B787OLOU10/$$+7Q-515Q Q520…
FDA’s list runs to 9,107 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
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.
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Jan 20, 2022.
- FDA classified it on Apr 21, 2022.
- FDA’s Enforcement Report published it on Apr 27, 2022.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- SIGHT DIAGNOSTICS LTD, of Tel Aviv-Yafo, Israel.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: E-Mail.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 9,107 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.