Sight OLO CBC Test Kit, Model/Catalog Number: TK1. A disposable cartridge and sample preparation tools for use with the
Summary
The FDA issued a Class II for Sight OLO CBC Test Kit, Model/Catalog Number: TK1. A disposable cartridge and sa by SIGHT DIAGNOSTICS LTD. Reason: 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 bia.
Details
Source
Device Recall
External ID
Z-2173-2024
Action Date
2024-07-03
Status
Ongoing
Category
device
Product Description
Sight OLO CBC Test Kit, Model/Catalog Number: TK1. A disposable cartridge and sample preparation tools for use with the Sight OLO CBC analyzer.
Lot/Code Info: REF: TK1, UDI-DI: B787TK10, Lot Code: 10114
Quantity Affected: 7,450 units (2,800 US, 4,650 OUS)
Reason for Recall
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.
Distribution
Worldwide - US Nationwide distribution in the states of AL, FL, MS, TX, WI and the countries of Canada, Israel, Slovenia, Trinidad & Tobago.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-05-13
Company
Tel Aviv-Yafo
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 167 device recalls issued in the same week, part of 403 device-related FDA actions this month.
SIGHT DIAGNOSTICS LTD has 4 FDA actions in our database, including 4 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (SIGHT DIAGNOSTICS LTD) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does SIGHT DIAGNOSTICS LTD have FDA actions?
SIGHT DIAGNOSTICS LTD has 4 FDA actions in our database, including 4 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2173-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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