Radioimmunoassay, Follicle-stimulating Hormone

DiagnosUS One Step FSH Menopausal Test (Strip) REF 210-07

Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, DiagnosUS SARS-CoV-2 Antibody (IgG/IgM) Test, HealthyWiser KetoFast" Ketone Test Strips and PrestiBio" Ketone Test Strips without marketing authorization. UMI is also recall their tests because they are going out of business and would not be able to continue fulfilling any post-market responsibilities of these distributed products. UMI claims to hold 510(k)s for the other devices, purchased the intellectual property in 2015 from the previous 510(k) holder, but FDA has been unable to verify this information. The devices may have unknown performance characteristics because the firm is unable to provide any documentation that the devices were manufactured in conformance with the Quality System regulation, including documentation (e.g., DHF) that the distributed devices had not been modified since original clearance in a way that could impact their safety and effectiveness, documentation of controlled storage temperature/humidity, and post-market surveillance documentation, such as complaints and adverse events.

VIDAS FSH, Ref 30407-01, IVD, Rx. The firm name on the label is bioMerieux SA, France.

Invalid calibration with low calibrator S1 while using the product.

DELFIA hFSH kit. In Vitro Diagnostic for the determination of hFSH in serum

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 -11.3% bias was observed at an hFSH target concentration of 101 IU/L. The change observed in the serum samples within the range 1.76 67.0 IU/L hFSH averaged -2.9%. The reference range of the assay spans 0.60 to 98.0 IU/L.

Laparoscope, general; plastic surgery

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 exposed after shield deployment. Further use of any affected product should cease immediately. The affected model number is CTB71, and the affected lot is 1179107.

ADVIA Centaur FSH Assay: ADVIA Centaur Calibrator B

ADVIA Centaur Prolactin Assay and FSH, Calibrator B fails the analytical sensitivity stated in the IFU for lots below 40

VITROS Immunodiagnostic Products - FSH Reagent Pack

The recalling firm determined that biased results may occur for specific VITROS Immunodiagnostic Products (MicroWell Assays) at biotin concentrations which are lower than indicated in the current Instructions For Use (IFU). Patients who are taking biotin supplements could potentially have biased sample results for affected assays at biotin concentrations lower than indicated in the current IFU.

VIDAS FSH, REF 30407-01

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 results as the user must run another test.

VITROS Immunodiagnostic Products FSH Reagent Pack- IVD

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 quality control (QC) and patient samples at the low end of the Measuring (Reportable) Range when using VITROS FSH, LH and Prol Reagent. Calibration failures, driven by imprecision observed with Calibrator Level 1.

ST-AIA PACK FSH; Part Number: 025265

Asfotase Alfa (Strensiq) interferes with certain Tosoh assays which potentially causes falsely increased or falsely decreased immunoassay test results, depending upon the assay.