FDA Medical Device Recalls (openFDA)
Beckman Coulter Inc.: Beckman Coulter, IVD, REF: OSR61171, IgA, 4 x 14 mL R1, 4 x 11 mL R2
- Recall number
- Z-2488-2023
- Recalling firm
- Beckman Coulter Inc.
- Product
- Beckman Coulter, IVD, REF: OSR61171, IgA, 4 x 14 mL R1, 4 x 11 mL R2
- Status
- Open, Classified
- Initiated
- 2023-07-12
- Posted
- 2023-08-31
- Terminated
- not on file
- Reason
- Lipemic interference failed to meet the performance specification listed within the IFU.
- Root 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
- 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.
- Lot, serial or model codes
- All Lots/UDI-(01)15099590011574
- 510(k) numbers
- K073489
- PMA numbers
- not on file
- Product code
- CFN
- Firm FEI
- 2050012
- Firm city
- Brea
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28