—#187544

Product

Access SARS-CoV-2 lgG II Calibrator, REF C69058, IVD, CE UDI: (01)15099590742751

FDA product code: QKO — Reagent, Coronavirus Serological
Device class: Class N
Medical specialty: Unknown
Affected lot / code info: All Lots

Why it was recalled

SARS-CoV-2 lgG II numerical results may potentially be multiplied by a factor of 1000 on systems running with assay protocol file (APF) and access assay file (AAF) versions resulting in falsely elevated numerical values.

Root cause (FDA determination)

Software Design Change

Action the firm took

On May 7, 2021, Beckman Coulter issued an "URGENT MEDICAL DEVICE RECALL" to affected consignees. The notification was emailed and sent via First Class Mail. In addition to informing consignees about the recall, the firm ask consignees to take the following actions: 1. Do not install any of the APF/AAF versions listed in the table. 2. Determine your current APF/AAF version. " From the Main Menu: select Configure F8 System Setup F1 System Revisions F1. " Verify the APF/AAF version displayed on the screen. 3 If the APF/AAF version is listed in the table: " Stop using the Access SARS-CoV-2 IgG II assay. Contact the Beckman Coulter Customer Technical Support Center at 1-800-854-3633 for further instruction. " Review all Access SARS-CoV-2 IgG II patient test results from April 13, 2021 onward. " Do not install any additional APF/AAF versions prior to contacting Beckman Coulter. 4. If the APF/AAF version is lower than those listed in the table, you are not impacted. Continue operating your system under existing instructions. 5. Please share this information with your laboratory staff and retain this notification as part of your laboratory Quality System documentation. If you have forwarded any of the affected product(s) listed above to another laboratory, please provide them a copy of this letter. 6. So that we are assured you have received this important communication, please respond within 10 days in one of the following ways: " Electronically, if you received this communication via email. " Manually, complete and return the enclosed Response Form. 7. If you have any questions regarding this notice, please contact our Customer Support Center: " From our website: http://www.beckmancoulter.com " By phone: call 1-800-854-3633 in the United States.

Recalling firm

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

Distribution

Distribution pattern: US: Alabama, Alaska, Arizona, Arkansas, California, Florida, Georgia, Illinois, Iowa, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Mississippi, Missouri, New Hampshire, New Jersey, New York, North Dakota, Ohio, Oklahoma, Pennsylvania, Puerto Rico, Tennessee, Texas, Virginia, West Virginia, Wisconsin, Wyoming, OUS: Andorra, Austria, Croatia, Czech Republic, France, Germany, Gibraltar, Greece, Hong Kong, Hungary, Israel, Italy, Japan, Jordan, Poland, Portugal, San Marino, Slovakia, Slovenia, Spain, United Arab Emirates

Timeline

Recall initiated: 2021-05-07
Terminated: 2023-03-27
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #187544. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.