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Class 2 Device Recall ACCESS SARSCoV2 ANTIGEN QC |
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Date Initiated by Firm |
July 01, 2021 |
Create Date |
August 12, 2021 |
Recall Status1 |
Terminated 3 on June 14, 2023 |
Recall Number |
Z-2257-2021 |
Recall Event ID |
88261 |
Product Classification |
Coronavirus antigen detection test system. - Product Code QKP
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Product |
ACCESS SARS-CoV-2 ANTIGEN QC, REF: C68670, CONTENTS: 3 X 6.0 mL QC1, 3 x 6.0 mL QC2, 1 QC VALUE CARD, IVD, Rx Only, UDI: (01)15099590742737;
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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 |
Customer Support Center 1800-854-3633
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Manufacturer Reason for Recall |
SARS-CoV-2 Antigen Assay test may generate false positive results which could result in incorrect diagnosis .
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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 |
544 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
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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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