Class 2 Device Recall Beckman Coulter IgA

• Date Initiated by Firm: July 12, 2023
• Date Posted: August 31, 2023
• Recall Status: Open, Classified
• Recall Number: Z-2488-2023
• Recall Event ID: 92729
• 510(K)Number: K073489
• Product Classification: Method, nephelometric, immunoglobulins (g, a, m) - Product Code CFN
• Product: Beckman Coulter, IVD, REF: OSR61171, IgA, 4 x 14 mL R1, 4 x 11 mL R2
• Code Information: All Lots/UDI-(01)15099590011574
• Recalling Firm/ Manufacturer: Beckman Coulter Inc.; 250 S Kraemer Blvd; Brea CA 92821-6232
• For Additional Information Contact: Marguerita Sweeney; 714-961-5321
• Manufacturer Reason for Recall: Lipemic interference failed to meet the performance specification listed within the IFU.
• FDA Determined Cause: Other
• Action: On July 18, 2023 Beckman Coulter issued a "Urgent Medical Device Recall" Notification via email and postal mail. Beckman Coulter asked consignees to take the following action: 1. No retrospective re view of past patient results is required however Beckman Coulter recommends sharing the content of this letter with your laboratory and/or medical director regarding the need to review previous patient test results. 2. Discontinuance or disposal of this product is not necessary. 3. Per the IFU, avoid highly lipemic samples when using the IgA assay. 4. No update is required to the LIH influences check settings on the analyzer, where in use. 5. Please share this information with your laboratory staff nd retain this notification as part of your laboratory Quality System documentation. If you have forwarded any of the affected product listed above to another laboratory, please provide them a copy of this letter. 6. So that we are assured you have received this important communication, please respond within 10 days in one of the following ways: - Electronically - If you received this communication via email, Manually - complete and return the enclosed Response Form. 7. If you have any questions regarding this notice, please contact our Customer Support Center - www.beckmancoulter.com or 1-800-854-3633 8. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
• Quantity in Commerce: 12,850 units
• 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = CFN and Original Applicant = OLYMPUS AMERICA INC.