AU/DxC AU Chemistry Transferrin REF: OSR6152 recallZ-0309-2024 · Beckman Coulter Biomedical Division · initiated Sep 6, 2023

Why it was recalled

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.

FDA root cause category: Nonconforming Material/Component

What the company is doing

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: [email protected] 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.

Recall details

Recall number

Z-0309-2024

Status

Open, Classified

Initiated by the company

Sep 6, 2023

Posted by the FDA

Nov 16, 2023

Recalling firm

Beckman Coulter Biomedical Division

Quantity

2,754

Product code

DDD

FDA submissions

K963139

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.

Product description

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.

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

• AU OSR6152

  Beckman Coulter, Inc. · Transferrin, Rhodamine, Antigen, Antiserum, Control
  1 recall0 reports