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Pointe Scientific, Inc.
HORIBA INSTRUMENTS INCORPORATED · Model F1029-96 · UDI-DI 00811727013248
CGJ
Prescription
10
510(k) clearances
32
Adverse events
9
Recalls
54
Facilities
Description
FSH for the quantitative determination of FSH concentration in human serum. The assay is useful in the diagnosis and treatment of pituitary and gonadal disorders. 96 Tests.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-05-22 | Universal Meditech Inc. | Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, DiagnosUS SARS-CoV-2 Antibody (IgG/IgM) Test, HealthyWiser KetoFast" Ketone Test Stri |
| 2022-03-25 | Ortho-Clinical Diagnostics, Inc | Falsely high or delayed patient and QC results may occur due to low end imprecision. VITROS Immunodiagnostic Products FSH, LH and Prol Reagents Low End Imprecision. Low-level quali |
| 2021-09-22 | bioMerieux, Inc. | bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to potential delayed result |
| 2018-07-12 | Ortho Clinical Diagnostics Inc | The recalling firm determined that biased results may occur for specific VITROS Immunodiagnostic Products (MicroWell Assays) at biotin concentrations which are lower than indicated |
| 2018-04-09 | BioMerieux SA | Invalid calibration with low calibrator S1 while using the product. |
| 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. |
| 2016-11-16 | PerkinElmer Health Sciences, Inc. | A DELFIA hFSH kit lot failed real time stability testing. The real time stability data demonstrated a decrease in hFSH concentrations between -4.8% to -11.3% for control sera. The |
| 2012-11-05 | Applied Medical Resources Corp | Applied Medical is conducting a voluntary recall on a specific lot number of its 12x150mm Kii shielded bladed access systems. This is due to a potential for the blade to remain exp |
| 2012-08-07 | Siemens Healthcare Diagnostics, Inc | ADVIA Centaur Prolactin Assay and FSH, Calibrator B fails the analytical sensitivity stated in the IFU for lots below 40 |
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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.