Recalls / —

—#202349

Product

Beckman Coulter, IVD, REF: OSR61171, IgA, 4 x 14 mL R1, 4 x 11 mL R2

FDA product code

CFN — Method, Nephelometric, Immunoglobulins (G, A, M)

Device class

Class 2

Medical specialty

Immunology

510(k) numbers

K073489

Affected lot / code info

All Lots/UDI-(01)15099590011574

Why it was recalled

Lipemic interference failed to meet the performance specification listed within the IFU.

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm

Beckman Coulter Inc.

Address

250 S Kraemer Blvd, Brea, California 92821-6232

Distribution

Distribution pattern

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.

Timeline

Recall initiated

2023-07-12

Posted by FDA

2023-08-31

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #202349. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.