FDA Medical Device Recalls (openFDA)
Beckman Coulter, Inc.: Beckman Coulter Access Free T3, Triiodothyronine, Free, Catalog #A13422, each box contains 2 reagent packs.
- Recall number
- Z-1419-2023
- Recalling firm
- Beckman Coulter, Inc.
- Product
- Beckman Coulter Access Free T3, Triiodothyronine, Free, Catalog #A13422, each box contains 2 reagent packs.
- Status
- Open, Classified
- Initiated
- 2023-03-15
- Posted
- 2023-04-20
- Terminated
- not on file
- Reason
- The reagent lot produces elevated results (approximately >30%) in some (15-20%)patient samples that do not correlate with the results of other thyroid markers nor Free T3 results generated on other platforms. This introduces a risk of the positive bias not being detected by QC with the potential that clinical correlation with other thyroid function tests will be inconsistent requiring additional testing; however the clinical assessment and treatment decisions are not made in isolation on a single test result especially, in the setting of thyroid function testing. False positive test results could lead to a euthyroid patient being interpreted clinically as having elevated thyroid function (hyperthyroid) or a hypothyroid patient being within the normal range. Such misdiagnoses may lead to inappropriate treatment of a euthyroid patient with anti-thyroid medications or hypothyroid patient not getting sufficient treatment since their free T3 test result demonstrates them to be in the euthyroid range.
- Root cause
- Process design
- Action
- The recalling firm issued letters dated 3/8/2023 via mail and email. The letter described the issue, impact, and actions to be taken. The actions included discontinuing use of the affected lot and discard all remaining reagent packs from this lot. The letter is to be shared with the consignee laboratory and/or medical director regarding the need to review previous patient test results. The consignee is to contact their local Beckman Coulter representative for replacement product requests. If the product has been forwarded to another laboratory, the consignee is requested to provide them a copy of the letter. A response was requested within 10 days via email or completion and return of the enclosed response form. The response form is to indicate the letter has been read and understood and all relevant personnel have been informed of its contents. The consignee is also to indicate whether or not they had the affected product.
- Quantity
- 31,076 units
- Distribution
- Worldwide distribution - US Nationwide, including Puerto Rico and the countries of Bahrain, Brazil, Canada, China, Costa Rica, El Salvador, Georgia, Hong Kong, Malaysia, Mexico, Myanmar, New Zealand, Peru, Philippines, Qatar, Singapore, Taiwan, Thailand, Uruguay, and Viet Nam.
- Lot, serial or model codes
- Lot #233968, exp. 2023-06-30, UDI (01)15099590201661(17)230630(11)220630(10)233968.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- CDP
- Firm FEI
- 2122870
- Firm city
- Chaska
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
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