FDA Medical Device Recalls (openFDA)
Beckman Coulter Biomedical Division: AU/DxC AU Chemistry Transferrin REF: OSR6152 Immune complexes formed in solution scatter light in proportion to their size, shape and concentration. Turbidimeters measure the reduction of incident light due to reflection, absorption, or scatter. In the procedure, the measurement of the decrease in light transmitted (increase in absorbance) through particles suspended in solution as a result of complexes formed during the antigen-antibody reaction, is the basis of this assay.
- Recall number
- Z-0309-2024
- Recalling firm
- Beckman Coulter Biomedical Division
- Product
- AU/DxC AU Chemistry Transferrin REF: OSR6152 Immune complexes formed in solution scatter light in proportion to their size, shape and concentration. Turbidimeters measure the reduction of incident light due to reflection, absorption, or scatter. In the procedure, the measurement of the decrease in light transmitted (increase in absorbance) through particles suspended in solution as a result of complexes formed during the antigen-antibody reaction, is the basis of this assay.
- Status
- Open, Classified
- Initiated
- 2023-09-06
- Posted
- 2023-11-16
- Terminated
- not on file
- Reason
- The firm has identified that the Transferrin reagent does not meet the Instructions for Use (IFU) reagent on-board stability claims, which may cause control failures and/or erroneous patient samples results. The Complaint handling unit has received a total of 2 safety cases (CASE-2023-02027212 and CASE-2023-02045278) and 99 quality cases with the failure mode attributed to Transferrin reagent (OSR6152 / lot 2573) associated with reagent blank shifts for the Reagent 2 (R2), imprecision, calibration failures, erratic Quality Control (QC) recoveries, and/or erroneous high/low (serum, plasma, urine) patient results. The issue was confirmed through internal testing by Beckman Coulter on June 30, 2023. Reagent Blank shifts for R2, imprecision, calibration failures, erratic Quality Control (QC) recoveries, and/or erroneous high/low (serum, plasma, urine) patient results. The issue was confirmed through internal testing by Beckman Coulter on June 30, 2023.
- Root cause
- Nonconforming Material/Component
- Action
- On 9/6/23, recall notices were mailed and emailed to customers who were asked to do the following: 1) Discontinue use of affected transferrin. 2) Contact firm for replacement lots. 3) No retrospective review of past patient results is required but this may be carried out at the discretion of the Laboratory Director. 4) Share this information with laboratory staff and retain the notification as part of your laboratory Quality System documentation. If you have forwarded any of the affected product listed above to another laboratory, provide them a copy of this letter. 5) Complete and return the response form via email to Email: regaffairsfax@beckman.com Questions can be directed to the Customer Support Center via website: http://www.beckmancoulter.com or phone: 1-800-854-3633 in the United States.
- Quantity
- 2,754
- Distribution
- Worldwide - US Nationwide distribution including in the states of NY, CA, MS, GA, PA, SC, WA, TN, AL, AK, OR, MO, KS, FL, LA, OH, TX, NJ, MI, WV, MD, IL, RI, VA, NC, IN, OK, NV, NE, WY, KY, WI, ND, MA, NH, UT, CO, GU, PR, AR, AZ, ME and the countries of Canada, Netherlands, United Kingdom, Sweden, Germany, France, Switzerland, Tunisia, Australia, Belgium, Costa Rica, Uruguay, Turkey, South Africa, New Zealand, Italy, Thailand, Ghana, Russia, Hungary, Czech Republic, Slovakia, India, Austria, Poland, Romania, Ireland, Spain, Portugal, Mexico, Vietnam, Korea, Mozambique, Kazakhstan, China, Malaysia, Singapore, Kenya, Brazil, Namibia, Egypt, Panama.
- Lot, serial or model codes
- UDI-DI: 15099590010492, LOT: 2573, Expiration: 01 August 2024
- 510(k) numbers
- ["K963139"]
- PMA numbers
- not on file
- Product code
- DDD
- Firm FEI
- 1000206808
- Firm city
- not on file
- Firm state
- not on file
- Firm country
- Ireland
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