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U.S. Department of Health and Human Services

Class 2 Device Recall Access SARSCoV2 Antigen Calibrators

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  Class 2 Device Recall Access SARSCoV2 Antigen Calibrators see related information
Date Initiated by Firm July 01, 2021
Create Date August 12, 2021
Recall Status1 Terminated 3 on June 14, 2023
Recall Number Z-2256-2021
Recall Event ID 88261
Product Classification Coronavirus antigen detection test system. - Product Code QKP
Product Access SARS-CoV-2 Antigen Calibrators, Catalog, REF: C68669, Contents: 1x2.5 mL C0, 1x2.5mL C1, 1x CAL CARD, UDI: (01)15099590742720;
Code Information All Lots
Recalling Firm/
Manufacturer		 Beckman Coulter Inc.
250 S Kraemer Blvd
Brea CA 92821-6232
For Additional Information Contact Customer Support Center
1800-854-3633
Manufacturer Reason
for Recall		 SARS-CoV-2 Antigen Assay test may generate false positive results which could result in incorrect diagnosis .
FDA Determined
Cause 2		 Other
Action On 07/09/2021 Beckman Coulter issued an "URGENT MEDICAL DEVICE RECALL" to all affected consignees via email and US Postal Mail. In addition to informing consignees about the recalled device, the firm ask consignees to take the following actions: 1. Immediately discontinue using the Access SARS-CoV-2 Antigen assay. 2. Discard all Access SARS-CoV-2 Antigen reagent packs. 3. At the discretion of the Laboratory Medical Director, consider updating previous laboratory reports to indicate prior Reactive laboratory results may not be accurate. 4. 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. 5. 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. 6. 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. " Outside the United States contact your local Beckman Coulter representative.
Quantity in Commerce 451 units
Distribution US Nationwide Distribution in the states of Alabama Alaska Arizona Arkansas California Connecticut Delaware Florida Georgia Idaho Illinois Indiana Iowa Kentucky Louisiana Maine Maryland Massachusetts Michigan Mississippi New Hampshire New Jersey New York North Carolina Ohio Oklahoma Oregon Pennsylvania Puerto Rico Tennessee Texas Virginia West Virginia, Wisconsin OUS: New Zealand, Libya
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.
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