Z-0110-2016Class II

Access Free T3 Reagent Kit, P/N A13422 The Access Free T3 assay is a paramagnetic particle, chemiluminescent...

Name: Z-0110-2016 Access Free T3 Reagent Kit, P/N A13422 The Access Free T3 assay is a paramagnetic particle, chemiluminescent...
Creator: Beckman Coulter Inc.
Published: 2015-08-31
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2015-08-31 / Terminated

FDA source

Beckman Coulter Inc. began a recall of Access Free T3 Reagent Kit, P/N A13422 The Access Free T3 assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of... on 2015-08-31. FDA classified it as Class II and gives the reason as "Beckman Coulter, Inc. is recalling Access Free T3 Reagent Kit because they were filled incorrectly and contain insufficient quantity of reagents in one or more of the pack wells". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0110-2016
Classification: Class II
Status: Terminated
Initiated: 2015-08-31
Posted: 2015-10-07
Terminated: 2016-05-16
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Access Free T3 Reagent Kit, P/N 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: Beckman Coulter, Inc. is recalling Access Free T3 Reagent Kit because they were filled incorrectly and contain insufficient quantity of reagents in one or more of the pack wells.
FDA root cause: Under Investigation by firm
Action: Beckman Coulter sent an " Urgent Medical Device Recall" letter dated August 31, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. The letter informs the customers that some Access Free T3 reagent packs (p/n A13422) of lot 431433 were filled incorrectly and contain insufficient quantity of reagents in one or more of the pack wells. Customers are instructed to complete and return the enclosed response form within 10 days. Customers with any questions regarding the notice are instructed to contact Customer Support Center at http://ww.beckmancoulter.com; call (800) 854-3633 in US and Canada. Customers outside of US and Canada are instructed to contact their local Beckman Coulter representative.
Quantity in commerce: 16,648 units total (1874 units in US)
Distribution: Worldwide Distribution - US (nationwide) and to the countries of : Australia, Brazil, Canada, China, Colombia, Costa Rica, Hong Kong, Israel, Japan, Kuwait, Macao, Malaysia, Mexico, New Zealand, Saudi Arabia, Singapore, Taiwan, Thailand and Viet Nam.
Product codes and lots: Lot: 431433

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0110-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0110-2016	Class II	Terminated	Voluntary: Firm initiated	2015-10-14	2015-10-07

Product code CDP

K960913Class IIAccess Free T3 AssayBio-Rad Laboratories, Inc. / cleared 1996-03-29

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)