DIAGNOSTICA STAGO

After receiving customer complaints, investigations confirmed the presence of a positive bias in D-Dimer measurements throughout the entire analytical range.

The potential of out-of-range results and an underestimation of the free protein S level in normal patient plasmas. The defect only affects normal-range values.

Potential for defect for Asserachrom HPIA lot 271288, which can affect every well in the impacted strip and produce negative results.

A potential risk of underestimation of D-Dimer (D-Di) levels with the two listed lots.

Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH applications.

Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH applications.

Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH applications.

Potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in UFH and LMWH applications.

Potential for shorter clotting times in clotting tests which have a dilution, leading to possible overestimate of around 1%

An internal investigation identified a bug in this firmware version, resulting in the following:Intermittent shortened coagulation times and an increased frequency of occurrence of a technical error reported by the analyzer (error 13).

An internal investigation identified a bug in this firmware version, resulting in the following:Intermittent shortened coagulation times and an increased frequency of occurrence of a technical error reported by the analyzer (error 13).

An internal investigation identified a bug in this firmware version, resulting in the following:Intermittent shortened coagulation times and an increased frequency of occurrence of a technical error reported by the analyzer (error 13).

A risk of sample-to-sample cross-contamination of Emicizumab for factor VIII assays on Stago instruments, clotting times will be shortened that may cause factor VIII levels reported to be falsely increased

A positive bias was confirmed to exists on the STA - Unicalibrator levels with STA - Deficient IX and STA - Deficient VIII when compared to the International Standard (IS) for factor VIII or IX. This bias is also observed on several External Quality Assessment (EQA) results.

A positive bias was confirmed to exists on the STA - Unicalibrator levels with STA - Deficient IX and STA - Deficient VIII when compared to the International Standard (IS) for factor VIII or IX. This bias is also observed on several External Quality Assessment (EQA) results.

There have been reports of shortened (T1-T2) results, where some instances of result recovery outside of the range of less than or equal to 15 seconds.

There have been reports of shortened (T1-T2) results, where some instances of result recovery outside of the range of less than or equal to 15 seconds.

QC values outside of the assigned ranges (prolonged Prothrombin time / decreased PT %)

QC values outside of the assigned ranges (prolonged Prothrombin time / decreased PT %)

Confirmed defect of homogeneity where some reagent vials will give prolonged Prothrombin Time (decreased PT%).

Confirmed defect of homogeneity where some reagent vials will give prolonged Prothrombin Time (decreased PT%).

Confirmed defect of homogeneity where some reagent vials will give prolonged Prothrombin Time (decreased PT%).

Confirmed defect of homogeneity where some reagent vials will give prolonged Prothrombin Time (decreased PT%).

Diagnostica Stago Inc. received some customer complaints regarding a misreading of Reagent 1 (substrate) barcode on STA analyzers.

Diagnostica Stago has confirmed that sometimes the delta OD measured can be changed leading to a lowered percentage result.

Following a single customer complaint that incorrect INR values were occasionally printed for PT tests, even though the primary units (seconds) were correct, the firm investigated and confirmed the potential for printing incorrect secondary units when using an external printer and the customer printout mode on the STA Satellite.

Factor VIII quality control results are being recovered below the assigned ranges for STA System Control N+P.

Internal investigation has determined the potential lack of homogeneity between product vials.

Internal investigation has determined the potential lack of homogeneity between product vials.

Incorrect results. Internal investigation determined the presence of a defective measurement head which can impact the results of clotting tests by either yielding no result or rendering an error message.

Specific lots of STA Liatest Free Protein S may result in low results in the assigned value ranges and sometimes outside the lower limit.

Based on the confirmed clotting times in the upper part of the assigned ranges of STA-Coag Control ABN control plasmas when used with STA-Neoplastine CI Plus, use of this lot may cause difficulty during the validation of the STA-Coag Control ABN.

A dose-hook effect is observed starting from VWF:AG levels of 300%, while the package insert indicates that no dose-hook effect has been observed with VWF:Ag levels up to 800%.

Result of complaints of field failures of the silicon bridge rectifier, resulting in smoke billowing out of the unit and burnt circuit boards, wires and connectors.

Decrease in sensitivity ; This could result in a false negative result for patients with weak to moderate lupus anticoagulants.

The mean levels (%) of normal and abnormal control plasmas (STA Liatest Control N and P) obtained with STA Liatest Free Protein S are found in the lower part of the range.

Concerning the STA-R blood coagulation analyzer, there is a possible failure mode associated with patient samples receiving prolonged exposure time to reagents during the cuvette roll change process.

Variable clotting times observed with the PTT-LA, Lupus Anticoagulant-Sensitive APTT Reagent.

With maintenance of the STA line, the cap-piercing feature may involve potential risk of needle puncture injury.

Incorrect assay ranges on the assay value insert for Heparin Control 5.

The FDP Plasma latex reagent (Reagent Vial 1) is more sensitive which may result in a weak agglutination at low concentration of FDPs.