Beckman Coulter Inc.: Access Immunoassay Systems Thyroglobulin, Part Number: 33860 This device is intended to aid in monitoring for the presence of local and metastatic thyroid tissue in patients who have had thyroid gland ablation (using thyroid surgery with or without radioactivity) and who lack serum thyroglobulin antibodies.

Recall number

Z-2215-2011

Recalling firm

Beckman Coulter Inc.

Product

Access Immunoassay Systems Thyroglobulin, Part Number: 33860 This device is intended to aid in monitoring for the presence of local and metastatic thyroid tissue in patients who have had thyroid gland ablation (using thyroid surgery with or without radioactivity) and who lack serum thyroglobulin antibodies.

Status

Terminated

Initiated

2010-10-18

Posted

2011-05-19

Terminated

2012-08-10

Reason

The recall was initiated because In addition to Access Tg Sample Diluent, an additional diluent, Access Wash Buffer II, was added to Thyroglobulin instructions for use (IFU) for evaluation of samples having Tg levels above the reportable range of the assay. When customers interchange between diluents there is an unacceptable shift in results. A median difference of 16% (ranging from 14% to 23%) b

Root cause

Other

Action

The firm, Beckman Coulter, sent an "URGENT: PRODUCT CORRECTIVE ACTION (PCA)" letter dated October 18, 2010, with attached PCA Response Form (via US Postal Service for US Customers) to all customers who purchased the Access Immunoassay Systems Thyroglobulin. The letter describes the product, problem and actions to be taken. The customers were instructed to: 1. Do not dilute elevated thyroglobulin samples with Wash Buffer II. 2. Do not run thyroglobulin patient samples using the onboard dilution feature on the UniCel DxI instrument. 3. Dilute elevated thyroglobulin samples only with Access Thyroglobulin Sample Diluent (REF 33866). 4. Review your patient result archives. Manually dilute and repeat the analysis of all elevated thyroglobulin samples that had previously been diluted with Wash Buffer II, using Access Thyroglobulin Sample Diluent instead. 5. A forthcoming version of the UniCel DxI Assay Protocol File (APF) will remove the Access Thyroglobulin onboard dilution assay (dTg) from the list of available onboard dilution assays. 6. The Access Tg product Instructions for Use will be updated to eliminate Wash Buffer II as an acceptable diluent for elevated thyroglobulin samples. Customers should update procedure manuals and other documents that your laboratory may have created which list Wash Buffer II as an acceptable diluent for elevated thyroglobulin samples. In addition, customers were instructed to complete and return the enclosed PCA Response Form with in 10 days via fax to: 786-639-4000 or mail to: Beckman Coulter, Inc., 1000 Lake Hazeltine Drive, Chaska, MN 55318, Attn: Regulatory Affairs. Customers with any technical questions regarding the Product Corrective Action were instructed to contact Beckman's Customer Support Center on the Beckman Coulter website at http://www.beckmancoulter.com/customersupport/support or call (800) 854-3633 in the US and Canada. Outside the US and Canada, customers were instructed to contact their local Be

Quantity

6,414 units

Distribution

Worldwide distribution: USA (nationwide) and country of: Canada.

Lot, serial or model codes

All lot numbers

510(k) numbers

["K002905","K031269"]

PMA numbers

not on file

Product code

MSW

Firm FEI

2050012

Firm city

Brea

Firm state

CA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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