Z-1670-2021Class II

Access SARS-CoV-2 Antigen, REF C68668, UDI: (01)15099590742713, 3.30 mL/R1a, 4.70 mL/R1b, 4.20 mL/R1c, 3.10...

Name: Z-1670-2021 Access SARS-CoV-2 Antigen, REF C68668, UDI: (01)15099590742713, 3.30 mL/R1a, 4.70 mL/R1b, 4.20 mL/R1c, 3.10...
Creator: Beckman Coulter Inc.
Published: 2021-04-14
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2021-04-14 / Terminated

FDA source

Beckman Coulter Inc. began a recall of 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 on 2021-04-14. FDA classified it as Class II and gives the reason as "specimens collected in transport media may result is false negative results when stored in certain conditions". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1670-2021
Classification: Class II
Status: Terminated
Initiated: 2021-04-14
Posted: 2021-05-21
Terminated: 2023-05-19
Recalling firm: Siemens Healthcare Diagnostics Inc.
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
Product code: QKP Coronavirus Antigen Detection Test System.
Reason for recall: specimens collected in transport media may result is false negative results when stored in certain conditions.
FDA root cause: 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, 20-25C, 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:
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.
Product codes and lots: All Lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1670-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1670-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-02	2021-05-21

Product code QKP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)