Sight Diagnostics Ltd

Complete recall history across all FDA and CPSC categories — 4 total recalls

Sight Diagnostics Ltd appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (4)

FDA medical device enforcement actions by Sight Diagnostics Ltd

Date Product Reason Class
May 13, 2024 Sight OLO CBC Test Kit, Model/Catalog Number: TK1. A disposable cartridge and... One Test Kit lot (TK1-10114) shows a positive bias in the platelet count due ... Class II
Jun 14, 2022 Sight OLO, Automated Hematology Analyzer, Catalog No. OLO-U1 The default reference ranges for MCH, MCHC, and RDW for age group "Child 2-11... Class II
Jan 20, 2022 The Sight OLO device is a computer vision based platform for blood analysis. ... In instances where custom reference ranges were configured on the device post... Class II
Mar 17, 2021 Sight OLO-E1/U1 Software and Operators Manual Software v2.56.1 Catalog #: 1... Discrepancy in labeling between the adult CBC reference ranges presented in t... Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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