AU/DxC AU Chemistry Transferrin REF: OSR6152 Immune complexes formed in solution scatter light in proportion to their s
Summary
The FDA issued a Class II for AU/DxC AU Chemistry Transferrin REF: OSR6152 Immune complexes formed in solutio by Beckman Coulter Biomedical Division. 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 c.
Details
Source
Device Recall
External ID
Z-0309-2024
Action Date
2023-11-22
Status
Ongoing
Category
device
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.
Lot/Code Info: UDI-DI: 15099590010492, LOT: 2573, Expiration: 01 August 2024
Quantity Affected: 2,754
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.
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-09-06
Company
County Clare, N/A
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 200 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Beckman Coulter Biomedical Division) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Beckman Coulter Biomedical Division have FDA actions?
This is the only FDA action we have on record for Beckman Coulter Biomedical Division in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0309-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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