Z-2108-2016Class II

Access Free T3 Assay, Ref No. A13422 The Access Free T3 assay is a paramagnetic particle, chemiluminescent...

Name: Z-2108-2016 Access Free T3 Assay, Ref No. A13422 The Access Free T3 assay is a paramagnetic particle, chemiluminescent...
Creator: Beckman Coulter Inc.
Published: 2016-06-08
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2016-06-08 / Terminated / root cause: design

FDA source

Beckman Coulter Inc. began a recall of Access Free T3 Assay, Ref No. A13422 The Access Free T3 assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of... on 2016-06-08. FDA classified it as Class II and gives the reason as "Demonstrate an upward shift in patient results". 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-2108-2016
Classification: Class II
Status: Terminated
Initiated: 2016-06-08
Posted: 2016-06-30
Terminated: 2017-04-18
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Access Free T3 Assay, Ref No. A13422 The Access Free T3 assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of free triiodothyronine levels in human serum and plasma using the Access Immunoassay Systems.
Product code: CDP Radioimmunoassay, Total Triiodothyronine
Reason for recall: Demonstrate an upward shift in patient results.
Root cause tag: design
FDA root cause: Device Design
Action: Beckman Coulter sent an " Urgent Medical Device Recall" letter dated June 8, 2016, to all affected customers. Beckman Coulter has determined through customer feedback and internal testing that the Access Free T3 Reagent lots listed above demonstrate an upward shift in patient results. The preliminary results indicate this upward shift may be related to a June 2015 formulation design change that was introduced to improve the Access Free T3 open reagent pack stability. The upward shift in patient test results, therefore, is expected to be maintained for all future lots. The letter informs the customers of the impact and the actions to be taken. Customers are instructed to complete and return the enclosed response form within 10 days. Customers with any questions are instructed to contact Customer Technical Support Center at http:www.beckmancoulter.com, call (800) 854-3633 in US and Canada. Customers outside US and Canada, are instructed to contact local Beckman Coulter representative.
Quantity in commerce: 205,744 kits total (13,358 kits in US)
Distribution: Worldwide Distribution - US Distribution and to the countries of : Algeria, Australia, Austria, Bangladesh, Belgium, Bolivia, Bosnia and Herzegovina, Botswana, Brazil, Brunei Darussalam, Bulgaria, Canada, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Djibouti, Ecuador, Egypt, El Salvador, Estonia, France, Germany, Ghana, Gibraltar, Greece, Guam, Honduras, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kuwait, Lebanon, Lithuania, Macao, Malaysia, Mayotte, Mexico, Morocco, Namibia, Netherlands, New Zealand, Nigeria, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Russian Federation, Rwanda, Saudi Arabia, Serbia, Sierra Leone, Singapore, Slovakia, South Africa, Spain, Swaziland, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Viet Nam, Zambia, Zimbabwe
Product codes and lots: 524087 526807 528874 529913 530102 531647 532473 534080 534081 534336 535481 570090 570116 570222 570236 570239 570245 570246 622173 622174 671016 671025 671033

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2108-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2108-2016	Class II	Terminated	Voluntary: Firm initiated	2016-07-06	2016-06-30

Product code CDP

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)