Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported August 3, 2022
Sight OLO, Automated Hematology Analyzer, Catalog No. OLO-U1
The default reference ranges for MCH, MCHC, and RDW for age group "Child 2-11y" are mixed up and incorrectly displayed on OLO devices running software version 2.63, 2.63.1, and 2.…
Sight Diagnostics LTD recalled Sight OLO, Automated Hematology Analyzer, Catalog No. OLO-U1 - a moderate-severity action.
Sight OLO, Automated Hematology Analyzer, Catalog No. OLO-U1 was recalled by Sight Diagnostics LTD in August 3, 2022. Reason: The default reference ranges for MCH, MCHC, and RDW for age group "Child 2-11y" are mixed up and incorrectly …. Check the official notice for the remedy. Verify recall #Z-1469-2022 with the FDA Devices before acting.
The recall
Sight Diagnostics LTD issued this moderate-severity FDA Devices recall-The default reference ranges for MCH, MCHC, and RDW for age group "Child 2-11y" are mixed up and incorrectly ….
- Moderate
- severity level
- Class II
- classification
- August 3, 2022
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1469-2022 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1469-2022) was formally reported on August 3, 2022, with the manufacturer initiating the action on June 14, 2022. It is classified under Moderate severity (Class II), with a current status of Ongoing. Sight Diagnostics LTD is listed as the recalling firm, operating out of Tel Aviv-Yafo. Federal records list the affected scope as 72 US; 292 OUS.
The documented reason for this recall is: The default reference ranges for MCH, MCHC, and RDW for age group "Child 2-11y" are mixed up and incorrectly displayed on OLO devices running software version 2.63, 2.63.1, and 2.63.1.1. Due to the issue, results may in… Distribution data in the federal record shows the product reached: Worldwide distribution - US Nationwide distribution in the states of Alabama, Arizona, California, Florida, Idaho, Illinois, Kansas, Kentucky, Massachusetts, Michigan, Minnesota, Mississippi, New Jersey, Ohio, Pennsylv…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
72 US; 292 OUS
Related Recalls
6
3 from same agency
Product description
Sight OLO, Automated Hematology Analyzer, Catalog No. OLO-U1
Reason for recall
The default reference ranges for MCH, MCHC, and RDW for age group "Child 2-11y" are mixed up and incorrectly displayed on OLO devices running software version 2.63, 2.63.1, and 2.63.1.1. Due to the issue, results may incorrectly appear to be within or outside the reference range.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-1469-2022 |
| Date reported | August 3, 2022 |
| Date initiated | June 14, 2022 |
| Recalling firm | Sight Diagnostics LTD |
| Firm location | Tel Aviv-Yafo |
| Affected scope | 72 US; 292 OUS |
| Distribution | Worldwide distribution - US Nationwide distribution in the states of Alabama, Arizona, California, Florida, Idaho, Illinois, Kansas, Kentucky, Massachusetts, Michigan, Minnesota, Mississippi, New Jersey, Ohio, Pennsylvania, South Carolina… |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1469-2022) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
Sight OLO, Automated Hematology Analyzer, Catalog No. OLO-U1. Recalled by Sight Diagnostics LTD. Units affected: 72 US; 292 OUS.
Why was this product recalled? ▼
The default reference ranges for MCH, MCHC, and RDW for age group "Child 2-11y" are mixed up and incorrectly displayed on OLO devices running software version 2.63, 2.63.1, and 2.63.1.1. Due to the issue, results may incorrectly appear to be within or outside the reference range.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 3, 2022. Severity: Moderate. Recall number: Z-1469-2022.
Where was the recalled product distributed? ▼
Distribution: Worldwide distribution - US Nationwide distribution in the states of Alabama, Arizona, California, Florida, Idaho, Illinois, Kansas, Kentucky, Massachusetts, Michigan, Minnesota, Mississippi, New Jersey, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington, Wisconsin and the countries of Burkina Faso, Belize, Canada, Cote D'Ivoire, Cameroon, Curacao, Germany, Spain, Finland, United Kingdom, Greece, Hong Kong, Indonesia, Ireland, Israel, India, Italy, Mexico, Portugal, Qatar, Sweden, Slovenia, Chad, Thailand, South Africa..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1469-2022) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
Nearby Recalls in This Category
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported August 3, 2022. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.