Z-3027-2011

Access Immunoassay Systems Total T4 Calibrators, Part Number: 33805, Subsequent

Name: Z-3027-2011 Access Immunoassay Systems Total T4 Calibrators, Part Number: 33805, Subsequent
Creator: Beckman Coulter Inc.
Published: 2010-08-26
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2010-08-26 / Terminated / root cause: manufacturing process

FDA source

Beckman Coulter Inc. began a recall of Access Immunoassay Systems Total T4 Calibrators, Part Number: 33805, Subsequent Product Code: JIS The Access Total T4 Calibrators are intended to calibrate the... on 2010-08-26. The reason FDA records is "The recall was initiated because Beckman Coulter has confirmed that the stability claims for the Access Total T4 calibrators may not be met. This issue is associated with calibrator lots 917074 and 008534". 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-3027-2011
Status: Terminated
Initiated: 2010-08-26
Posted: 2011-08-16
Terminated: 2012-07-11
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Access Immunoassay Systems Total T4 Calibrators, Part Number: 33805, Subsequent Product Code: JIS 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.
Product code: KLI Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine
Reason for recall: The recall was initiated because Beckman Coulter has confirmed that the stability claims for the Access Total T4 calibrators may not be met. This issue is associated with calibrator lots 917074 and 008534.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Beckman Coulter sent an "URGENT: PRODUCT CORRECTIVE ACTION" letter dated September 13, 2010 to all affected customers. The letter describes the product, problem, and the actions to be taken by the customers. The letter instructs customers to discontinue use of the affected lot numbers and review historical quality control performance. Additionally, a response form was attached to the letter for customers to complete and return. Alternate lots will be provided for current and future replenishment orders or requests. Customers with questions regarding this notification can call Technical Support at (800) 854-3633 or contact their local Beckman Coulter representative.
Quantity in commerce: 2495 units total (2492 in US)
Distribution: Worldwide Distribution-USA (nationwide) and the country of Canada.
Product codes and lots: Lot Number: 917074, 008534 Expiration Date: 917074 (12/31/10), 008534 (2/28/11)

Product code KLI

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)