Z-2178-2011

Beckman Coulter Access Free T3 Calibrators, Part Number A13430 in vitro diagnostic

Name: Z-2178-2011 Beckman Coulter Access Free T3 Calibrators, Part Number A13430 in vitro diagnostic
Creator: Beckman Coulter Inc.
Published: 2009-12-17
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2009-12-17 / Terminated / root cause: manufacturing process

FDA source

Beckman Coulter Inc. began a recall of Beckman Coulter Access Free T3 Calibrators, Part Number A13430 in vitro diagnostic on 2009-12-17. The reason FDA records is "Beckman Coulter has confirmed reports that the Access Free T3 calibrator lot numbers 989902, 989903, 989904, 989905, 989906 and 989907 will show a decline in performance before reaching their stated expiration date. The...". 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-2178-2011
Status: Terminated
Initiated: 2009-12-17
Posted: 2011-05-10
Terminated: 2012-03-29
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Beckman Coulter Access Free T3 Calibrators, Part Number A13430 in vitro diagnostic.
Product code: JIT Calibrator, Secondary
Reason for recall: Beckman Coulter has confirmed reports that the Access Free T3 calibrator lot numbers 989902, 989903, 989904, 989905, 989906 and 989907 will show a decline in performance before reaching their stated expiration date. The affected calibrator lots will cause one or more quality control samples to produce out-of-range high result.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Beckman Coulter sent a letter dated December 29, 2009, providing the customers with an explanation of the reason for recall and asked them to take the following actions: - Discontinue use of the lots of reagent listed above. - Review your historical quality control to ensure that the assay performance of these lots has been within your laboratory specifications. NOTE: Out-of-range high quality control results may indicate invalid test results. Consignees were asked to share this information with their laboratory staff and retain this notification as part of their laboratory Quality System documentation; and complete and return the enclosed response form within 10 days so that Beckman can be assured that they received this important notification. Assistance or questions regarding this notification, were directed to Technical Support at 1-800-854-3633 in the United States and Canada. Outside the United States and Canada, contact consignees were told to contact their local Beckman Coulter Representative.
Quantity in commerce: 2,320 kits
Distribution: Distribution Nationwide and Canada.
Product codes and lots: Lot #'s: 989902, 989903, 989904, 989905, 989906 & 989907

Product code JIT

K042651Class IIFree T3 Calibrators on the Access Immunoassay SystemsBeckman Coulter, Inc. / cleared 2004-10-05

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)