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Elecsys FT4 IV
Roche Diagnostics GmbH · Model 09043276160 · UDI-DI 07613336175071
CEC
Prescription
1
510(k) clearances
1,922
Adverse events
12
Recalls
43
Facilities
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2019-04-30 | Beckman Coulter Inc. | 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 |
| 2018-11-21 | Abbott Ireland Diagnostics Division | 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 n |
| 2018-03-05 | Tosoh Bioscience Inc | Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay. |
| 2018-01-02 | Siemens Healthcare Diagnostics, Inc. | 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 C |
| 2017-05-09 | Beckman Coulter Inc. | The Access immunoassays are susceptible to biotin interference. |
| 2013-11-08 | Qualigen Inc | Qualigen initiated this recall because the FastPack kit may cause lower than expected results due to a manufacturing defect. |
| 2010-11-11 | Beckman Coulter Inc. | 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 res |
| 2010-04-12 | Siemens Healthcare Diagnostics, Inc. | 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 re |
| 2010-03-24 | Beckman Coulter Inc. | 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 Vita |
| 2003-05-30 | Abbott Laboratories HPD/ADD | The Free T4 Controls, may yield control values that are high and outside of the package insert ranges. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.