Dimension Vista LOCI CA 15-3 Flex reagent cartridge. In Vitro Diagnostic for the quantitative measurement of CA 15-3.
Summary
The FDA issued a Class II for Dimension Vista LOCI CA 15-3 Flex reagent cartridge. In Vitro Diagnostic for th by Siemens Healthcare Diagnostics, Inc.. Reason: Negative bias with patient samples. The mean patient sample bias range from -26% to -33%,potential risk of delay in appropriate treatment and manageme.
Details
Source
Device Recall
External ID
Z-1648-2022
Action Date
2022-09-07
Status
Ongoing
Category
device
Product Description
Dimension Vista LOCI CA 15-3 Flex reagent cartridge. In Vitro Diagnostic for the quantitative measurement of CA 15-3. Siemens Material Number (SMN)/Ref Catalog Number : 10464344/K6456
Lot/Code Info: UDI: 0084276802852621340BB22120610464344840, 0084276802852622049BC23021810464344840, 0084276802852622112BF23042210464344840. Lot Numbers: lot 21340BB Exp Date: 2022-12-06; lot 22049BC (corrected lot number 9/8/2022) Exp Date: 2023-02-18; lot 22112BF Exp Date: 2023-04-20.
Quantity Affected: 129 units US; 159 units OUS
Reason for Recall
Negative bias with patient samples. The mean patient sample bias range from -26% to -33%,potential risk of delay in appropriate treatment and management decisions.
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, Austria, France, ¿¿ Germany, Italy, Switzerland.
Type: Voluntary: Firm initiated
Recall Initiated: 2022-07-18
Company
Newark, DE
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 164 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Siemens Healthcare Diagnostics, Inc. has 166 FDA actions in our database, including 142 recalls and 24 clearances.
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 (Siemens Healthcare Diagnostics, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Siemens Healthcare Diagnostics, Inc. have FDA actions?
Siemens Healthcare Diagnostics, Inc. has 166 FDA actions in our database, including 142 recalls and 24 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1648-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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