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U.S. Department of Health and Human Services

Class 2 Device Recall Transferrin reagent (Product ID: OSR6152)

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  Class 2 Device Recall Transferrin reagent (Product ID: OSR6152) see related information
Date Initiated by Firm September 06, 2023
Date Posted November 16, 2023
Recall Status1 Open3, Classified
Recall Number Z-0309-2024
Recall Event ID 93206
510(K)Number K963139  
Product Classification Transferrin, rhodamine, antigen, antiserum, control - Product Code DDD
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.
Code Information UDI-DI: 15099590010492, LOT: 2573, Expiration: 01 August 2024
Recalling Firm/
Manufacturer		 Beckman Coulter Biomedical Division
Lismeehan, O'Callaghan's Mills
County Clare Ireland
For Additional Information Contact
(0)65 683 1100
Manufacturer 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.
FDA Determined
Cause 2		 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 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = DDD and Original Applicant = OLYMPUS AMERICA, INC.
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