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.
Sight Diagnostics is recalling a specific lot of Sight OLO CBC Test Kit (TK1-1011:10114) because bacterial contamination causes false high platelet counts. This could lead to incorrect health assessments if used without the recall fix.
Bacterial contamination in one specific lot (TK1-10114) causes the test kit to show falsely elevated platelet counts by 7.5 k/ul. This means the test results could be inaccurate, potentially leading to incorrect health assessments.
Users of the Sight OLO CBC Test Kit (model TK1) with lot code 10114 are affected. People using this kit for blood tests may be at risk of inaccurate results.
Check for the model number TK1 on the test kit and lot code 10114. The kit is sold with the Sight OLO CBC analyzer.
Reach out to Sight Diagnostics for instructions on how to handle the affected test kit lot.
The specific lot (TK1-10114) has bacterial contamination causing false high platelet counts, but the hazard is not severe enough to require immediate stop use.
Check for model TK1 and lot code 10114 on the test kit. The kit is used with the Sight OLO CBC analyzer.
Contact Sight Diagnostics for instructions on handling the affected lot.
We’ve drafted a message you can send Sight Diagnostics to request your refund or repair — edit it as you like.
Subject: Recall Z-2173-2024 — Sight Diagnostics Sight Diagnostics Hello, I own a Sight Diagnostics that is covered by recall Z-2173-2024 from Sight Diagnostics. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
