DxU 850m Iris Urine Microscopy Analyzer Catalog Number C49513, in-vitro diagnostic device, urine analysis
Summary
The FDA issued a Class II for DxU 850m Iris Urine Microscopy Analyzer Catalog Number C49513, in-vitro diagnost by Beckman Coulter, Inc.. Reason: Beckman Coulter has become aware of an intermittent issue in which the optional flag "Previous Sample Had Sperm" was enabled but not displayed so that.
Details
Source
Device Recall
External ID
Z-1597-2023
Action Date
2023-05-24
Status
Ongoing
Category
device
Product Description
DxU 850m Iris Urine Microscopy Analyzer Catalog Number C49513, in-vitro diagnostic device, urine analysis
Lot/Code Info: UDI/DI 15099590748647, All analyzers with Windows 10, Software Versions 8.5, 8.5.1 and 8.6
Quantity Affected: 107 units
Reason for Recall
Beckman Coulter has become aware of an intermittent issue in which the optional flag "Previous Sample Had Sperm" was enabled but not displayed so that a carryover event could have been investigated.
Distribution
Worldwide Distribution
Type: Voluntary: Firm initiated
Recall Initiated: 2023-04-05
Company
Miami, FL
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 147 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Beckman Coulter, Inc. has 158 FDA actions in our database, including 111 recalls and 47 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 (Beckman Coulter, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Beckman Coulter, Inc. have FDA actions?
Beckman Coulter, Inc. has 158 FDA actions in our database, including 111 recalls and 47 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1597-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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