Z-1901-2025Class II

Access Testosterone assay, Catalog Number 33560

Name: Z-1901-2025 Access Testosterone assay, Catalog Number 33560
Creator: Beckman Coulter, Inc.
Published: 2025-05-05
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2025-05-05 / Open, Classified / root cause: manufacturing process

FDA source

Beckman Coulter, Inc. began a recall of Access Testosterone assay, Catalog Number 33560 on 2025-05-05. FDA classified it as Class II and gives the reason as "Inadequate preventative maintenance (PM) performed on the scales of the RPL5 fill line, led to splashing (cross-contamination) between the wells of testosterone reagent packs lot 538081, which could potentially result...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1901-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-05-05
Posted: 2025-06-02
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Access Testosterone assay, Catalog Number 33560
Product code: CDZ Radioimmunoassay, Testosterones And Dihydrotestosterone
Reason for recall: Inadequate preventative maintenance (PM) performed on the scales of the RPL5 fill line, led to splashing (cross-contamination) between the wells of testosterone reagent packs lot 538081, which could potentially result in up to a 34% increase or a 23% decrease in patient results.
Root cause tag: manufacturing process
FDA root cause: Equipment maintenance
Action: An URGENT MEDICAL DEVICE RECALL notification letter dated 4/23/25 was sent to customers. ACTION: Discontinue using and discard all remaining Access Testosterone reagent packs from the lot listed above. Beckman Coulter recommends performing a retrospective review on patient results generated with the Access Testosterone lot listed above and assessing the need for retesting. Contact your local Beckman Coulter representative for replacement product requests. Beckman Coulter is no longer distributing the affected Access Testosterone reagent pack lot number and has corrected the manufacturing issue that led to cross-contamination. 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. 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. If you have any questions regarding this notice, please contact our Customer Support Center: From our website: http://www.beckmancoulter.com If you need replacement product: o Complete the attached Replacement Order Form and email to [email protected] or fax to (866) 294-7850 OR o Call Client Services at (800) 526-3821
Quantity in commerce: 70 units
Distribution: US State: FL. UAE, Vietnam
Product codes and lots: UDI-DI: 15099590231347; Serial Number: 538081

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1901-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1901-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-06-11	2025-06-02

Product code CDZ

K223405Class IAccess TestosteroneBeckman Coulter, Inc. / cleared 2023-01-13

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)