Z-0613-2013Class II

Access Immunoassay Systems Total T4 Calibrators, Part Number: 33805. The Access Total T4 Calibrators are...

Name: Z-0613-2013 Access Immunoassay Systems Total T4 Calibrators, Part Number: 33805. The Access Total T4 Calibrators are...
Creator: Beckman Coulter Inc.
Published: 2011-07-27
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2011-07-27 / Terminated / root cause: manufacturing process

FDA source

Beckman Coulter Inc. began a recall of Access Immunoassay Systems Total T4 Calibrators, Part Number: 33805. The Access Total T4 Calibrators are intended to calibrate the Access Total T4 assay for... on 2011-07-27. FDA classified it as Class II and gives the reason as "A recall communication was initiated because Beckman has identified that Access Total T4 calibrator lots 019818, 021654, and 024072 do not meet their 12 month expiration date claim". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0613-2013
Classification: Class II
Status: Terminated
Initiated: 2011-07-27
Posted: 2012-12-22
Terminated: 2012-12-26
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Access Immunoassay Systems Total T4 Calibrators, Part Number: 33805. The Access Total T4 Calibrators are intended to calibrate the Access Total T4 assay for the quantitative determination of total thyroxine (T4) levels in human serum and plasma using the Access Immunoassay Systems. Total T4 assay results are used for diagnosis and confirmation of thyroid disorders such as hyper- and hypothyroidism.
Product code: JIS Calibrator, Primary
Reason for recall: A recall communication was initiated because Beckman has identified that Access Total T4 calibrator lots 019818, 021654, and 024072 do not meet their 12 month expiration date claim.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: A recall communication was initiated on July 27, 2011 with Beckman forwarding a Product Corrective Action (PCA) letter with attached PCA response form to all their customers who purchased the Access Immunoassay Systems Total T4 Calibrators. The letter provides the customers with an explanation of the problems identified and actions to be taken. Customers were instructed to complete and return the enclosed response form within 10 days. Customers can call for product replacement in the US, by contacting Client Services at (800) 526-3821, option 1. Customers in Canada can contact Customer service at (800) 463-7828. Customers with questions regarding this notice can contact Customer Support Center at http:www.beckmancoulter.com or call (800) 854-3633 in the US and Canada.
Quantity in commerce: 6,634 units total (2,742 units in US)
Distribution: Worldwide Distribution-USA (nationwide) and the countries of Argentina, Australia, Austria, Bangladesh, Belgium, Brazil, Canada, Chile, China, Colombia, Costa Rica, Czech Republic, Egypt, El Salvador, Ethiopia, France, Germany, Greece, India, Indonesia, Ireland, Italy, Japan, Jordan, Kazakhstan, Lebanon, Libyan Arab Jamahiriya, Liechtenstein, Macao, Malaysia, Mexico, Netherlands, Nigeria, Pakistan, Panama, Philippines, Puerto Rico, Romania, Russian Federation, Serbia, Singapore, Spain, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Venezuela, Viet Nam, and Zambia.
Product codes and lots: 019818, 021654, 024072

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0613-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0613-2013	Class II	Terminated	Voluntary: Firm initiated	2013-01-02	2012-12-22

Product code JIS

K023369Class IIAccess Total T4 AssayBeckman Coulter, Inc. / cleared 2002-12-09

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)