Beckman Coulter, IVD, REF: OSR61171, IgA, 4 x 14 mL R1, 4 x 11 mL R2
Summary
The FDA issued a Class II for Beckman Coulter, IVD, REF: OSR61171, IgA, 4 x 14 mL R1, 4 x 11 mL R2 by Beckman Coulter Inc.. Reason: Lipemic interference failed to meet the performance specification listed within the IFU..
Details
Source
Device Recall
External ID
Z-2488-2023
Action Date
2023-09-06
Status
Ongoing
Category
device
Product Description
Beckman Coulter, IVD, REF: OSR61171, IgA, 4 x 14 mL R1, 4 x 11 mL R2
Lot/Code Info: All Lots/UDI-(01)15099590011574
Quantity Affected: 12,850 units
Reason for Recall
Lipemic interference failed to meet the performance specification listed within the IFU.
Distribution
US: AL AR AZ CA CO CT DC DE FL GA IA IL IN KS KY LA MA MD MI MN MO MS NC ND NE NJ NM NY OH OK OR PA RI SC SD TN TX UT VA WA WI WV OUS: Algeria, Argentina, Australia, Austria, Bangladesh, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, China, Colombia, C¿te d'Ivoire, Croatia, Cura¿ao, Cyprus, Czechia, Denmark, Ecuador, Egypt, France, Germany, Gibraltar, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Kazakhstan, Korea, Republic of, Lebanon, Lithuania, Malaysia, Mayotte, Mexico, Morocco, Mozambique, Netherlands, New Zealand, Oman, Pakistan, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Russian Federation, San Marino, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Switzerland, Taiwan, Province of China, Tunisia, Turkey, United Arab Emirates, United Kingdom of Great Britain and Northern Ireland, Uruguay, Viet Nam, Yemen.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-07-12
Company
Brea, CA
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 154 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-2488-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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