Beckman Coulter IRISPEC CA/CB/CC Urine Chemistry Controls, Catalog Number REF 800-7211 and 800-7702, in vitro diagnostic
Summary
The FDA issued a Class III for Beckman Coulter IRISPEC CA/CB/CC Urine Chemistry Controls, Catalog Number REF 80 by Beckman Coulter, Inc.. Reason: Beckman Coulter has become aware of an increase in customer complaints for intermittent IRISpec CB negative glucose control failure, resulting in fals.
Details
Source
Device Recall
External ID
Z-0093-2025
Action Date
2024-10-23
Status
Ongoing
Category
device
Product Description
Beckman Coulter IRISPEC CA/CB/CC Urine Chemistry Controls, Catalog Number REF 800-7211 and 800-7702, in vitro diagnostic device.
Lot/Code Info: UDI/DI 10837461002611, Lot Numbers: 432-24 and higher
Quantity Affected: 5589 units
Reason for Recall
Beckman Coulter has become aware of an increase in customer complaints for intermittent IRISpec CB negative glucose control failure, resulting in false positive control results when used in conjunction with iChemVELOCITY Urine Chemistry Strips (PNs 800-7204 and 800-7212) on the iChemVELOCITY Analyzer. This issue may delay the reporting of patient results, with a worst-case scenario of a delay in diagnosis or treatment of metabolic disorders, kidney function abnormalities, urinary tract infections, and liver function.
Distribution
worldwide
Type: Voluntary: Firm initiated
Recall Initiated: 2024-07-16
Company
Miami, FL
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 180 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 III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
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-0093-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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