Access SARS CoV-2 lgG II Reagent, REF: C69057, IVD CE UDI: (01)15099590742744
- Company
- Beckman Coulter Inc.
- Recall Initiated
- May 7, 2021
- Terminated
- March 27, 2023
- Recall Number
- Z-1905-2021
- Quantity
- 13,337 units
- Firm Location
- Brea, CA
Reason for Recall
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.
Distribution
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
Lot / Code Info
All Lots
Root Cause
Software Design Change
Action Taken
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.