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Class 2 Device Recall SARS CoV2 Antigen |
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| Date Initiated by Firm |
April 14, 2021 |
| Create Date |
May 21, 2021 |
| Recall Status1 |
Terminated 3 on May 19, 2023 |
| Recall Number |
Z-1670-2021 |
| Recall Event ID |
87738 |
| Product Classification |
Coronavirus antigen detection test system. - Product Code QKP
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| Product |
Access SARS-CoV-2 Antigen, REF C68668, UDI: (01)15099590742713, 3.30 mL/R1a, 4.70 mL/R1b, 4.20 mL/R1c, 3.10 mL, R1d, 3.10 mL, R1e |
| 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
714-961-5321
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Manufacturer Reason
for Recall |
specimens collected in transport media may result is false negative results when stored in certain conditions.
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FDA Determined
Cause 2 |
Unknown/Undetermined by firm |
| Action |
On 4/14/2021, Becman Coulter issued an "Urgent Medical Device Recall" notice to all affected consignees via mail and E-Mail. In addition to informing consignees about the recall, the firm ask consignees to take the following actions:
1. Review the laboratory storage conditions for nasopharyngeal or nasal specimens that are collected in Bartels¿ FlexTrans" and Sigma Virocult¿ transport media. Evaluate the specimen storage conditions before and after extraction.
2 Review test results in the context of a patients history and clinical presentation for any specimens that were not stored according to the guidelines provided in the following tables:
Before Extraction:
Transport Media, Bartels FlexTrans Transport Medium Sigma Virocult, Revised Stability, 20-25¿C, 6 hrs. , 2-8¿C, 33 hrs.
After Extraction:
Transport Media, Bartels FlexTrans Transport Medium Sigma Virocult, Revised Stability, 20-25¿C, 10 min - 3 hrs., 2-8¿C, 6 hrs.
3. Limit of Detection:
A. The LoD for specimens collected in Bartels¿ FlexTrans" transport media has been amended from 33 TCID50/mL to 139 TCID50/mL.
B. No action is required in relation to the change in the limit of detection for Bartels¿ FlexTrans" transport media.
C. Update internal laboratory documentation as required.
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 listed above to another laboratory, please provide them a copy of this letter.
5. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDAs MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
6. Please complete and return the enclosed Response Form within 10 days so we are assured you have received this important communication.
7. If you have any questions regarding this notice, please contact our Customer Support Center:
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| Quantity in Commerce |
1,034 units |
| Distribution |
Worldwide distribution - US Nationwide distribution in the states of Alabama, 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 and the country of New Zealand. |
| 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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