Class 2 Device Recall ACCESS SARSCoV2 IgG QC

• Date Initiated by Firm: December 30, 2020
• Create Date: January 15, 2021
• Recall Status: Terminated on September 19, 2022
• Recall Number: Z-0875-2021
• Recall Event ID: 87146
• Product Classification: Reagent, coronavirus serological - Product Code QKO
• Product: ACCESS SARS-CoV-2 IgG QC SARS-CoV-2 IgG REF C58964 - Product Usage: use on the Access Family of Immunoassay Systems only.
• Code Information: Catalog Number: C58964 UDI Code: 15099590738662 Lot Number: 922407
• Recalling Firm/ Manufacturer: Beckman Coulter Inc.; 250 S Kraemer Blvd; Brea CA 92821-6232
• For Additional Information Contact: Annette Hellie; 714-961-4517
• Manufacturer Reason for Recall: The Quality Control (QC) card has a label error for the standard deviation (SD) values for one out of the two levels of QC.
• FDA Determined Cause: Labeling mix-ups
• Action: On or about 01/04/2021, the firm sent an "URGENT MEDICAL DEVICE RECALL" Notification to customer via mail or email informing them that the Recalling Firm has determined that the QC kit lot includes a Quality Control value card with an incorrect QC1 standard deviation (SD) value which may lead to a QC range that is too wide for the control level. Customers are instructed to: 1) Discard the incorrect QC value card included with the affected SARS-CoV-2 IgG quality control lot. 2) Use the Access SARS-CoV-2 IgG QC value card that is included with the Recall Notification letter in place of the discarded value card. 3) Review the QC1 SD value they have implemented and update if appropriate. Evaluate prior QC1 results against the correct SD value. If they detect unsatisfactory QC1 results, evaluate their previous test results. 4) Share this information with their laboratory staff and retain the recall notification as part of their laboratory Quality System documentation. 5) if the product has been forwarded to another laboratory, please provide the Recall Notification to them. 6) Complete and return/respond within 10 days to the Recall Notification: " Electronically, if they received the communication via email. " Manually, complete and return the enclosed Response Form. The Recalling Firm's actions: -They are no longer distributing the affected lot -All future lots will include a correct QC value card. Any questions - contact Customer Support Center at: " From our website: http://www.beckmancoulter.com " By phone: call 1-800-854-3633 in the United States. " Outside the United States contact your local Beckman Coulter representative.
• Quantity in Commerce: 276 units
• Distribution: Worldwide distribution - U.S. Nationwide distribution including in the states of AL, AZ, CA, FL, GA, IA, ID, IL, IN, KS,KY, LA, MD, MI, MN, MO, NC, ND, NY, OH, OK, OR, PA, Puerto Rico, SD, TX, WA, and WV. The countries of Andorra, Belgium, Brazil, Bulgaria, Canada*, Croatia, France, Germany, Hong Kong, Italy, Jordan, Mexico, Paraguay, Poland, Portugal, Romania, Spain, and United Kingdom.
• 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.