—#186886

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

FDA product code: QKP — Coronavirus Antigen Detection Test System.
Device class: Class N
Medical specialty: Unknown
Affected lot / code info: All Lots

Why it was recalled

specimens collected in transport media may result is false negative results when stored in certain conditions.

Root cause (FDA determination)

Unknown/Undetermined by firm

Action the firm took

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, 20-25C, 6 hrs. , 2-8C, 33 hrs. After Extraction: Transport Media, Bartels FlexTrans Transport Medium Sigma Virocult, Revised Stability, 20-25C, 10 min - 3 hrs., 2-8C, 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:

Recalling firm

Firm: Beckman Coulter Inc.
Address: 250 S Kraemer Blvd, Brea, California 92821-6232

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2021-04-14
Terminated: 2023-05-19
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #186886. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.