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Pointe Scientific, Inc.
HORIBA INSTRUMENTS INCORPORATED · Model T1008-96 · UDI-DI 00811727013156
CEC
Prescription
1
510(k) clearances
1,934
Adverse events
12
Recalls
43
Facilities
Description
Free T4 for the quantitative determination of Free Thyroxine (fT4) concentration in human serum. FOR RESEARCH USE ONLY. NOT FOR USE IN DIAGNOSTIC PROCEDURES. 96 Tests.
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.