—#185433

Product

ACCESS SARS-CoV-2 IgG QC SARS-CoV-2 IgG REF C58964 - Product Usage: use on the Access Family of Immunoassay Systems only.

FDA product code: QKO — Reagent, Coronavirus Serological
Device class: Class N
Medical specialty: Unknown
Affected lot / code info: Catalog Number: C58964 UDI Code: 15099590738662 Lot Number: 922407

Why it was recalled

The Quality Control (QC) card has a label error for the standard deviation (SD) values for one out of the two levels of QC.

Root cause (FDA determination)

Labeling mix-ups

Action the firm took

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.

Recalling firm

Firm: Beckman Coulter Inc.
Address: 250 S Kraemer Blvd, Brea, California 92821-6232

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2020-12-30
Terminated: 2022-09-19
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #185433. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.