Radioimmunoassay, Free Thyroxine

Beckman Coulter Access Immunoassay Systems, Access Free T4 Thyroxine, REF 33880 (UDI:15099590225834) for use with Access Family of Immunoassay Systems including

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.

Dimension Free Thyroxine (FT4L) Flex reagent cartridge

The concentrations for biotin listed in the non-interfering substances section of the instructions for use for the Dimension TSHL, Dimension LOCI FT4L, Dimension Vista TSH, ADVIA Centaur Cyclosporine, and ADVIA Centaur DHEAS, incorrectly state the level at which biotin does not interfere.

FastPack Free T4 Immunoassay

Qualigen initiated this recall because the FastPack kit may cause lower than expected results due to a manufacturing defect.

Access Free T4 Calibrator, Part Number: 33885, Lot Numbers: 014769

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.

The Dimension FT4L Flex reagent cartridge( Free Thyroxine) manufactured by Siemens Healthcare Diagnostics, Inc., Newark, DE.

Some LOCI cartridges have sub-optimal seal of the lidstock that can cause rupture of the package at high elevations, causing the cartridge to leak. Use of leaking cartridges may result in inaccurate test results.

Access Immunoassay Systems Free T4, Part Number: 33880

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.

Free T4 Control Pack, list 9C03-10; the kit consists of 3 bottles of controls, L - 0.7, M - 1.2 and H - 3.0; Abbott Laboratories, Abbott Park, IL 60064

The Free T4 Controls, may yield control values that are high and outside of the package insert ranges.

IMx Free T4 Reagent Kit, list 2222-20, 100 test kit; Abbott Laboratories, Abbott Park, IL 60064

The Free T4 Controls, may yield control values that are high and outside of the package insert ranges.

Architect Free T4 Calibrator Kit, list 7G96-01; the kit consists of 2 bottles of calibrators, CAL 1 - 0.5 and CAL 2 - 6.0; Abbott Laboratories, Abbott Park, IL

The Free T4 Controls, may yield control values that are high and outside of the package insert ranges.

Alinity i Free T4 Reagent Kit, List Number 07P7030

Abbott has become aware of a manufacturing issue that can result in damage to a bottle neck in some of the reagent cartridges found in the lots listed in Appendix A. If a bottle neck is damaged, it may cause a failure during the reagent loading process on the Alinity i instrument.