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Class 2 Device Recall Access SARS CoV2 lgG II Calibrator |
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| Date Initiated by Firm |
May 07, 2021 |
| Create Date |
June 21, 2021 |
| Recall Status1 |
Terminated 3 on March 27, 2023 |
| Recall Number |
Z-1906-2021 |
| Recall Event ID |
87960 |
| Product Classification |
Reagent, coronavirus serological - Product Code QKO
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| Product |
Access SARS-CoV-2 lgG II Calibrator, REF C69058, IVD, CE UDI: (01)15099590742751 |
| Code Information |
All Lots |
Recalling Firm/
Manufacturer |
Beckman Coulter Inc.
250 S Kraemer Blvd
Brea CA 92821-6232
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| For Additional Information Contact |
Annette Hellie
714-831-7388
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Manufacturer 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.
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FDA Determined
Cause 2 |
Software Design Change |
| Action |
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. |
| Quantity in Commerce |
3,843 units |
| 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 |
| Total Product Life Cycle |
TPLC Device Report
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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.
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