Recall Z-1419-2023 ยท CDP Radioimmunoassay, Total Triiodothyronine
Beckman Coulter, Inc.
Beckman Coulter Access Free T3, Triiodothyronine, Free, Catalog #A13422, each box contains 2 reagent packs.
| Date | Apr 20, 2023 (initiated Mar 15, 2023) |
| Status | Open, Classified |
| 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 co |
| 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 |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.