Z-2658-2010

Access Immunoassay Systems Free T4, Part Number: 33880

Name: Z-2658-2010 Access Immunoassay Systems Free T4, Part Number: 33880
Creator: Beckman Coulter Inc.
Published: 2010-03-24
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2010-03-24 / Terminated / root cause: labeling and UDI

FDA source

Beckman Coulter Inc. began a recall of Access Immunoassay Systems Free T4, Part Number: 33880 on 2010-03-24. The reason FDA records is "The recall was initiated after Beckman Coulter determined that kit boxes for Access Free T4 reagent (REF 33880), lot number 916293 may contain reagent packs labeled as Access Vitamin B12, (REF 33000), lot 916277. Using...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2658-2010
Status: Terminated
Initiated: 2010-03-24
Posted: 2010-10-01
Terminated: 2012-05-07
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Access Immunoassay Systems Free T4, Part Number: 33880
Product code: CEC Radioimmunoassay, Free Thyroxine
Reason for recall: The recall was initiated after Beckman Coulter determined that kit boxes for Access Free T4 reagent (REF 33880), lot number 916293 may contain reagent packs labeled as Access Vitamin B12, (REF 33000), lot 916277. Using an Access Vitamin B12 reagent pack, lot 916277, filled with Access Free T4 reagents may generate incorrect patient results.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: A Product Corrective Action (PCA) letter was sent on March 24, 2010 to the affected customers. The letter provides the customers with an explanation of the problem identified and instructs them to discard the FT4 kit, Lot 916293 in their stock if the FT4 packs within the kit packaging are labeled as Vitamin B12 Lot 916277. The PCA requested customers: (1) Inspect all Access Vitamin B12 reagent packs that have been removed from their kit boxes, including reagent packs currently loaded on your system and discard any reagent packs labeled as Access Vitamin B12, lot 916277; (2) Inspect your Access Free T4 reagent kit inventory for any reagent packs labeled as Access Vitamin B12, lot 916277 and discard any reagent packs labeled as Access Vitamin B12, lot 916277; (3) Review your historical quality control to ensure that assay performance for Access Vitamin B12 lot 916277 has been within your laboratory specifications. In addition customers were instructed to share this information with their laboratory staff and retain this notification as part of your laboratory Quality System documentation. Complete and return the enclosed response form within 10 days so Beckman Coulter can be assured that you have received this important notification. If customers need assistance or have any questions regarding the notification, they were instructed to contact Customer Technical Support Center at 1-800-854-3633 in the United States and Canada.
Quantity in commerce: 10826
Distribution: Nationwide In the US & Canada
Product codes and lots: Lot Number 916293

Product code CEC

K982250Class IIAccess Free T4 Reagents on the Access Immunoassay AnalyzerBeckman Instruments, Inc. / cleared 1998-07-14

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)