Radioimmunoassay, Free Thyroxine
Beckman Coulter, Inc.'s record for this product code
Recent MDR events
6 adverse event reports on file
- ACCESS® 2 IMMUNOASSAY SYSTEMOct 22, 2012Injury2122870-2012-01833
- ACCESS FREE T4 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZERApr 23, 2012Malfunction2122870-2012-01121
- ACCESS FREE T4 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZEROct 1, 2011Malfunction2122870-2011-04148
- ACCESS® FREE T4 CALIBRATORSSep 10, 2011Malfunction2122870-2011-03337
- ACCESS® FREE T4 ASSAYJul 19, 20112122870-2011-02159
- ACCESS® FREE T4 REAGENTJun 10, 2011Malfunction2122870-2011-01804
Recalls
4 recall events for this product code
- TerminatedJun 2, 2020
The recalling firm characterized the potential interference effects of biotin (up to 1,200 ng/mL) on all biotin-mediated Access assays. The following six assays: Free T3-REF A13422, Total T3-REF 33830, Free T4-REF 33880, GI Mon-387687, Tg-REF 33860, and TgAbII-REF A32898 displayed significant interference (defined as a result bias greater than +/-10%) at 1,200 ng/mL of biotin.
View FDA record ↗ - TerminatedApr 11, 2011
The recall was initiated because the stability claim for Access Free T4 calibrator lot 014769 is not met. The affected T4 calibrator lot can produce quality control and patient results that are erroneously low (by greater than 2 standard deviations). An erroneously low patient result may lead to misdiagnosis and/or delayed treatment.
View FDA record ↗ - TerminatedOct 1, 2010
The recall was initiated after Beckman Coulter determined that kit boxes for Access Free T4 reagent (REF 33880), lot number 916293 may contain reagent packs labeled as Access Vitamin B12, (REF 33000), lot 916277. Using an Access Vitamin B12 reagent pack, lot 916277, filled with Access Free T4 reagents may generate incorrect patient results.
View FDA record ↗ - TerminatedUnknown
The Access immunoassays are susceptible to biotin interference.
View FDA record ↗
510(k) clearances
1 clearances for this product code