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

FDA device recall Z-0309-2024 · posted 2023-11-16 · Open, Classified

Recall details

Recalling firm

Beckman Coulter Biomedical Division

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.

Action taken

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.

Root cause

Nonconforming Material/Component

Status

Open, Classified

Product code

DDD

Quantity affected

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

Date initiated

2023-09-06

Date posted

2023-11-16

Location

Ireland

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