Lower riskMedical device recall · FDA · Published May 13, 2024
Sight OLO CBC Test Kit Recall: Bacterial Contamination Causes False High Platelet Counts
Sight Diagnostics recalls specific lot of Sight OLO CBC Test Kit (TK1-10114) due to bacterial contamination causing false high platelet counts. Affected users should contact for remedy.
One Test Kit lot (TK1-10114) shows a positive bias in the platelet count due to bacterial contamination which can result in elevated counts with a bias of 7.5 k/ul. This results in the test kit lot performing outside of the device specification.
Take action
Contact the company
📍Recalling firmSIGHT DIAGNOSTICS LTD23, Derekh Menakhem Begin · Tel Aviv-Yafo, Israel
“Sight OLO CBC Test Kit Recall: Bacterial Contamination Causes False High Platelet Counts.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/55123-sight-olo-cbc-test-kit-recall-bacterial-contamination-causes-false. Based on FDA recall #Z-2173-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2173-2024%22&limit=1).
The FDA announced on May 13, 2024, that Sight Diagnostics is recalling the Sight OLO CBC Test Kit (Model TK1) due to bacterial contamination causing elevated platelet counts. Owners should contact the company for a replacement or refund.
One lot of the test kit shows a positive bias in the platelet count due to bacterial contamination, resulting in counts with a bias of 7.5 k/ul. This causes the kit to perform outside device specifications.
Context
GovInfoNow's records show Sight Diagnostics has issued three other recalls since March 17, 2021, including software errors and labeling discrepancies in 2022 and 2021. Other recent recalls of similar products include the Siemens Atellica CH Urine Albumin Recall (July 6, 2026), Beckman Coulter DxH Diluent Recall (Nov. 10, 2025), and Magellan LeadCare II Blood Lead Test Kits recall (March 13, 2026).
How to tell if you have this one
Check for the model number TK1 on the test kit and lot code 10114. The kit is sold with the Sight OLO CBC analyzer.
Brand
Sight Diagnostics
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Contact Manufacturer
Reach out to Sight Diagnostics for instructions on how to handle the affected test kit lot.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 5 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “Worldwide - US Nationwide distribution in the states of AL, FL, MS, TX, WI and the countries of Canada, Israel, Slovenia, Trinidad & Tobago.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Alabama, Florida, Mississippi, Texas, Wisconsin.
Recall timeline
FDA published this recall 51 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-2173-2024 (May 13, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2173-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.