BECKMAN COULTER IRISpec CA/CB/CC control, REF 900-7211, For in vitro diagnostic use only.
Summary
The FDA issued a Class II for BECKMAN COULTER IRISpec CA/CB/CC control, REF 900-7211, For in vitro diagnostic by Beckman Coulter, Inc.. Reason: Beckman Coulter has become aware of an increase in customer complaints generated for intermittent IRISpec CB glucose control false positive results wh.
Details
Source
Device Recall
External ID
Z-0777-2023
Action Date
2023-01-11
Status
Ongoing
Category
device
Product Description
BECKMAN COULTER IRISpec CA/CB/CC control, REF 900-7211, For in vitro diagnostic use only.
Lot/Code Info: UDI/DI 10837461002611, Lot 565-21: 11-30-2022
Quantity Affected: 3657 units
Reason for Recall
Beckman Coulter has become aware of an increase in customer complaints generated for intermittent IRISpec CB glucose control false positive results when used in conjunction with iChemVelocity Urine Chemistry Strips PN 800-7212
Distribution
US and Canada, Brazil, Korea, Mexico, Puerto Rico, Taiwan
Type: Voluntary: Firm initiated
Recall Initiated: 2022-11-18
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 162 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-0777-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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