Beckman Coulter Access Free T3 recall
Beckman Coulter Access Free T3, Triiodothyronine, Free, Catalog #A13422, each box contains 2 reagent packs.
Why was Beckman Coulter Access Free T3 recalled?
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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #233968, exp. 2023-06-30, UDI (01)15099590201661(17)230630(11)220630(10)233968.
- Product
- Beckman Coulter Access Free T3, Triiodothyronine, Free, Catalog #A13422, each box contains 2 reagent packs.
- Recalling firm
- Beckman Coulter, Inc.
- 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.
- Recall date
- April 26, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)