Access Total T3 Reagent recall
Access Total T3 Reagent, PN: 33830 The Access Total T3 assay is used for the quantitative determination of triiodothyronine (T3) levels in human serum…
Why was Access Total T3 Reagent recalled?
A recall was initiated because Beckman Coulter has identified a negative bias in test results when comparing elevated Total T3 patient samples diluted with Sample Diluent A to samples diluted with Access Total T3 Calibrator S0.
What should I do if I have this product?
Review the official FDA enforcement record for current 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?
All Lots
- Product
- Access Total T3 Reagent, PN: 33830 The Access Total T3 assay is used for the quantitative determination of triiodothyronine (T3) levels in human serum…
- Recalling firm
- Beckman Coulter Inc.
- Quantity
- 117,385 units total (33,918 units in US)
- Distribution
- Worldwide Distribution - USA (nationwide), Canada, and internationally.
- Recall date
- August 29, 2012
- Classification
- Class III
- Status
- Terminated
- Agency
- FDA (device)