Z-2227-2012Class III

Access Total T3 Reagent, PN: 33830 The Access Total T3 assay is used for the quantitative determination of...

Name: Z-2227-2012 Access Total T3 Reagent, PN: 33830 The Access Total T3 assay is used for the quantitative determination of...
Creator: Beckman Coulter Inc.
Published: 2011-10-11
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2011-10-11 / Terminated / root cause: design

FDA source

Beckman Coulter Inc. began a recall of Access Total T3 Reagent, PN: 33830 The Access Total T3 assay is used for the quantitative determination of triiodothyronine (T3) levels in human serum and... on 2011-10-11. FDA classified it as Class III and gives the reason as "A recall was initiated because Beckman Coulter has identified a negative bias in test results when comparing elevated Total T3 patient samples diluted with Sample Diluent A to samples diluted with Access Total T3...". 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-2227-2012
Classification: Class III
Status: Terminated
Initiated: 2011-10-11
Posted: 2012-08-20
Terminated: 2013-03-14
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Access Total T3 Reagent, PN: 33830 The Access Total T3 assay is used for the quantitative determination of triiodothyronine (T3) levels in human serum and plasma in the assessment of thyroid function and diagnosis of thyroid disorders when T3 levels are between 0.1 and 8.0 ng/mL.
Product code: CDP Radioimmunoassay, Total Triiodothyronine
Reason for recall: A recall was initiated because Beckman Coulter has identified a negative bias in test results when comparing elevated Total T3 patient samples diluted with Sample Diluent A to samples diluted with Access Total T3 Calibrator S0.
Root cause tag: design
FDA root cause: Device Design
Action: Beckman Coulter sent a Product Correction letter dated October 11, 2011, to all affected customers. The PCA letter informed the customers of the problem identified and the actions to be taken. Customers were informed to stop SDA usage as an alternative dilutent and that the S0 dilutent is to be used for manual dilution of the patient sample for Total T3. They will also be informed to no longer use the On Board Dilution (OBD) option for Total T3. Customers were instructed to complete and return the enclosed response form within 10 days. Customers with questions regarding this notification were instructed to contact Customer Support Center at http://www.beckmancoulter.com/customersupport/support or call (800) 854-3633 in the US and Canada. Outside of the US and Canada, customers were instructed to contact their local Beckman Coulter Representative. For questions regarding this recall call 714-961-4941.
Quantity in commerce: 117,385 units total (33,918 units in US)
Distribution: Worldwide Distribution - USA (nationwide), Canada, and internationally.
Product codes and lots: All Lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2227-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2227-2012	Class III	Terminated	Voluntary: Firm initiated	2012-08-29	2012-08-20

Product code CDP

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)