Access Free T4 Reagents on the Access Immunoassay Analyzer

• • Terminated Z-2237-2020 FDA Class II ·initiated 30 Apr 2019

  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.

• • Terminated Z-2637-2017 FDA Class II ·initiated 9 May 2017

  The Access immunoassays are susceptible to biotin interference.

• • Terminated Z-1945-2011 FDA Unclassified (pre-2012) ·initiated 11 Nov 2010

  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.

• • Terminated Z-2658-2010 FDA Unclassified (pre-2012) ·initiated 24 Mar 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.

510(k) Number

K982250 ↗

FDA Product Code

CEC

Device Class

Class II

Regulation

21 CFR Part 862.1695

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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