Recall Record

County Clare, N/A, Ireland

Beckman Coulter Biomedical Division recalls

1 recall recorded since 2018, most recently on 6 September 2023. 1 is listed as ongoing. Status and classification are as published by the FDA.

Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)0

Ongoing Class II Medical devices

Recall started
6 September 2023
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 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, G
Initiated
Voluntary: Firm initiated
Recall number
Z-0309-2024

A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.