Z-0309-2024Class II

AU/DxC AU Chemistry Transferrin REF: OSR6152 Immune complexes formed in solution scatter light in proportion...

Name: Z-0309-2024 AU/DxC AU Chemistry Transferrin REF: OSR6152 Immune complexes formed in solution scatter light in proportion...
Creator: Beckman Coulter Biomedical Division
Published: 2023-09-06
License: https://open.fda.gov/license/

Beckman Coulter Ireland Inc / initiated 2023-09-06 / Open, Classified / root cause: manufacturing process

FDA source

Beckman Coulter Biomedical Division began a recall of AU/DxC AU Chemistry Transferrin REF: OSR6152 Immune complexes formed in solution scatter light in proportion to their size, shape and concentration... on 2023-09-06. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0309-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-09-06
Posted: 2023-11-16
Recalling firm: Beckman Coulter Ireland Inc
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.
Product code: DDD Transferrin, Rhodamine, Antigen, Antiserum, Control
Reason for recall: 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 tag: manufacturing process
FDA 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: [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.
Quantity in commerce: 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.
Product codes and lots: UDI-DI: 15099590010492, LOT: 2573, Expiration: 01 August 2024

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0309-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0309-2024	Class II	Ongoing	Voluntary: Firm initiated	2023-11-22	2023-11-16

Product code DDD

K963139Class IIOlympus Transferrin Immunoturbidimetric ReagentOlympus America, Inc. / cleared 1997-02-06

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)