Z-3006-2020Class II

BECKMAN COULTER ACCESS Immunoassay Systems - Access Unconjugated Estriol, REF 33570

Name: Z-3006-2020 BECKMAN COULTER ACCESS Immunoassay Systems - Access Unconjugated Estriol, REF 33570
Creator: Beckman Coulter Inc.
Published: 2020-08-26
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2020-08-26 / Terminated

FDA source

Beckman Coulter Inc. began a recall of BECKMAN COULTER ACCESS Immunoassay Systems - Access Unconjugated Estriol, REF 33570 on 2020-08-26. FDA classified it as Class II and gives the reason as "Due to alkaline phosphatase (ALP) associated interference causing falsely elevated uE3 (Unconjugated Estriol assay) results". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-3006-2020
Classification: Class II
Status: Terminated
Initiated: 2020-08-26
Posted: 2020-09-24
Terminated: 2024-05-24
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: BECKMAN COULTER ACCESS Immunoassay Systems - Access Unconjugated Estriol, REF 33570.
Product code: CGI Radioimmunoassay, Estriol
Reason for recall: Due to alkaline phosphatase (ALP) associated interference causing falsely elevated uE3 (Unconjugated Estriol assay) results.
FDA root cause: Under Investigation by firm
Action: On 08/31/2020, the firm sent an "URGENT MEDICAL DEVICE RECALL" notification to customers via email and US Post informing them of the potential for an interference with bovine alkaline phosphatase (ALP) in a subset of patient samples tested with the Access Unconjugated Estriol (uE3) assay. Customers are instructed to: - Consider the patients total clinical presentation when interpreting results. - Any retrospective review of patient results is left to the discretion of the Medical Director. - Contact Beckman Coulter Technical Support if you suspect ALP associated interference and do not report the uE3 test result. - Share this information with their laboratory staff and retain this notification as part of their laboratory Quality System documentation. If they have forwarded any of the affected products to another laboratory, to please provide them with a copy of the Customer Notification letter. -Complete and return the enclosed Response Form within 10 days so that the Recalling Firm can be assured that customers have received the important communication. In the meantime, the Recalling Firm is actively working to resolve this issue by end of Q1, 2021. For any questions, please contact the Recalling Firm's Customer Support Center at: - website: http://www.beckmancoulter.com " phone: call 1-800-854-3633 in the United States and Canada. " Outside the United States and Canada contact your local representative.
Quantity in commerce: 21455 assay systems
Distribution: Worldwide distribution - U.S. Nationwide distribution including in the states of AL, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, LA, MA, MD, MI, MN, NC, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, WA, WI and Puerto Rico. The countries of Australia, Belgium, Bosnia and Herzegovina, Brazil, Canada, China, Czech Republic, Germany, Hungary, India, Ireland, Italy, Jordan, Lebanon, Malaysia, Mexico, Nepal, Pakistan, Panama, Portugal, Russia, Saudi Arabia, Serbia, Slovakia, South Africa, South Korea, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, and Vietnam.
Product codes and lots: Catalog Number: 33570 UDI Code: (01)15099590231187 Serial/Lot Numbers: 921133 921348 921742

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3006-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3006-2020	Class II	Terminated	Voluntary: Firm initiated	2020-09-30	2020-09-24

Product code CGI

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)