Z-2636-2017Class II

Access Thyroglobulin, A34085G, Catalog No. 33860

Name: Z-2636-2017 Access Thyroglobulin, A34085G, Catalog No. 33860
Creator: Beckman Coulter Inc.
Published: 2017-05-09
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2017-05-09 / Terminated / root cause: design

FDA source

Beckman Coulter Inc. began a recall of Access Thyroglobulin, A34085G, Catalog No. 33860 on 2017-05-09. FDA classified it as Class II and gives the reason as "The Access immunoassays are susceptible to biotin interference". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2636-2017
Classification: Class II
Status: Terminated
Initiated: 2017-05-09
Posted: 2017-06-28
Terminated: 2018-03-30
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Access Thyroglobulin, A34085G, Catalog No. 33860
Product code: MSW System, Test, Thyroglobulin
Reason for recall: The Access immunoassays are susceptible to biotin interference.
Root cause tag: design
FDA root cause: Device Design
Action: An urgent Medial Device Recall letter dated 5/9/17 was sent to customers to inform them that Beckman Coulter is initiating a field action for Access Total T3, Access Thyroglobulin, Access Free T4, and Access GI Monitor. Beckman Coulter has determined through customer feedback and an internal investigation that the four Access immunoassays listed above are susceptible to biotin interference. During interference testing the interference occurred with samples that contained 100 ng/mL of biotin. This level of biotin is greater than the maximum biotin concentration observed in the normal healthy population. Customers are informed of the impact, action, and resolution. Customers are instructed to respond within 10 days: electronically via email or manually by completing and returning the enclosed response form. Customers with any questions regarding the notice are instructed to contact Customer Technical Support Center: From our website: http://www.beckmancoulter.com By phone: call 1-800-854-3633 in the United States and Canada. Outside the United States and Canada, contact your local Beckman Coulter representative.
Quantity in commerce: 83,504 units total (23,285 units in US)
Distribution: Algeria, Angola, Australia, Austria, Bangladesh, Belgium, Bolivia, Bosnia and Herzegovina, Botswana, Brazil, Brunei, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Djibouti, Ecuador, Egypt, El Salvador, Estonia, Ethiopia, Finland, France, Georgia, Germany, Ghana, Gibraltar, Greece, Guam, Guatemala, Honduras, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kuwait, Lebanon, Libya, Lithuania, Macau, Malawi, Malaysia, Mayotte, Mexico, Morocco, Myanmar, Namibia, Nepal, Netherlands, Netherlands Antillean, New Zealand, Nigeria, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Russia, Rwanda, Saudi Arabia, Serbia, Sierra Leone, Singapore, Slovakia, South Africa, South Korea, Spain, Sri Lanka, Swaziland, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Uganda, United Arab Emirates, United Kingdom, United States, Uruguay, Venezuela, Vietnam, Zambia, Zimbabwe
Product codes and lots: all lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2636-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2635-2017	Class II	Terminated	Voluntary: Firm initiated	2017-07-05	2017-06-28
Z-2636-2017	Class II	Terminated	Voluntary: Firm initiated	2017-07-05	2017-06-28
Z-2637-2017	Class II	Terminated	Voluntary: Firm initiated	2017-07-05	2017-06-28
Z-2638-2017	Class II	Terminated	Voluntary: Firm initiated	2017-07-05	2017-06-28

Product code MSW

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)