Recall Z-2227-2012— Beckman Coulter Inc.
Class III · Terminated
Class III FDA medical device recall by Beckman Coulter Inc., initiated 2011-10-11, terminated 2013-03-14. It names 3 FDA 510(k) clearances: K973966, K955435, K940833. 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 and plasma in the assessment of thyroid function and diagnosis of thyroid disorders when T3 levels are between 0.1 and 8.0 ng/mL.. Reason: 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..
- Recalling firm
- Beckman Coulter Inc.
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2011-10-11
- Terminated
- 2013-03-14
- Firm location
- Brea, CA, United States
510(k) clearances named in this recall
3 on FDA's record- K973966 — ACCESS TOTAL T3 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER
- K955435 — ACCESS TOTAL T3 ASSAY (MODIFICATION)
- K940833 — ACCESS(R) TOTAL T3
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Access Total T3 Reagent, PN: 33830 The Access Total T3 assay is used for the quantitative determination of triiodothyronine (T3) levels in human serum and plasma in the assessment of thyroid function and diagnosis of thyroid disorders when T3 levels are between 0.1 and 8.0 ng/mL.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.