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DIAGNOSTICA STAGO INC

STA COMPACT · General Hospital

510(k): 1 Recall: 10 UDI: 0 MAUDE: 4 Class.: 66

Related Cybersecurity Alerts

Diagnostica Stago, Inc. — STA Compact Automated Multi-Parametric Analyzer, Reference Numbers 58602 and 58612
HIGH · FDA · 2023-03-22
Diagnostica Stago, Inc. — STA Compact Max fully automatic clinical analyzer, Reference Numbers 58602 and 58612
HIGH · FDA · 2023-03-22

510(k) Clearances (1)

STA COMPACT AUTOMATED MULTI-PARAMETRIC ANALYZER
2009-12-22

Substantially Equivalent

Recalls (10)

Brand Name: STA Liatest D-Di Product Name: STA Liatest D-Di Model/Catalog Number: REF 00515 Product Description: in vitro diagnostic. The STA - Liatest D-Di kit is an assay for the quantitative determination of D-dimer in venous plasma for use on STA-R, STA Compact and STA Satellite analyzers by
2026-02-05

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

Brand Name: STA Liatest Free Protein S Product Name: STA Liatest Free Protein S Model/Catalog Number (REF): 00516 Product Description: The STA - Liatest Free Protein S kits are intended for use on STA-R and STA Compact for the quantitative antigenic assay of free protein S in human citrated plasma b
2026-02-04

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.

STA - Owren Koller. Model/Catalog Number: 00360 STA - Owren-Koller is a buffer solution intended for use as a diluent for reagents and human plasmas in coagulation tests performed with analyzers of the STA-R, STA Compact, STA Satellite and ST art families.
2025-05-21

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

STA Compact Automated Multi-Parametric Analyzer, Reference Numbers 58602 and 58612
2023-03-22

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).

STA Compact Max fully automatic clinical analyzer, Reference Numbers 58602 and 58612
2023-03-22

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).

STA - Deficient VIII, Product Code: 00725. STA - Deficient VIII is an immuno-depleted human plasma intended for use in tests for the determination of factor VIII activity in plasma on STA-R and STA Compact analyzer platforms as follows: (A) STA-R Max, Product Codes: 58989, 58990 (B) STA-R Evolution,
2020-03-04

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

STA Compact and STA Compact CT, Haemostasis Analyzer, in vitro diagnostic.
2007-07-30

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.

STA Compact and STA Compact CT For in vitro Diagnostic Use Only In vitro diagnostic analyzer Diagnostica Stago France
2007-01-18

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.

STA-Compact Hemostasis System with Cap piercing capability.
2003-03-05

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

STA Heparin Control kit used on STA analyzers (STA, STA Compact, STAR). The STA heparin control kit is a set of two plasmas containing different levels of unfractionated heparin (UFH) intended for the quality control of UFH assays performed on STA analyzers. Each kit contains 6 x 1 mL vials of Rea
2002-12-20

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

MAUDE Adverse Events (4)

Injury
20250424
Malfunction
20131014
Malfunction
20070121
Malfunction
20040807

FDA Classification (66)

Digital Physical/Chemical Sterilization Process Sensor

General Hospital

Set, Blood Transfusion

General Hospital

Washer Of Body Waste Receptacles

General Hospital

Sterilizer, Dry Heat

General Hospital

Respirator, N95, For Use By The General Public In Public Health Medical Emergencies

General Hospital

Infusion Safety Management Software

General Hospital

Vascular Access Port Kit

General Hospital

Tubing, Fluid Delivery

General Hospital

Basin, Emesis

General Hospital

Oral Administration Set

General Hospital

Ear Irrigation Kit

General Hospital

Nursing Pad, Cohesive Gel

General Hospital

Stocking, Medical Support (To Prevent Pooling Of Blood In Legs)

General Hospital

Bottle, Collection, Vacuum

General Hospital

Thoracentesis Tray

General Hospital

Delivery Room Apparel Kit

General Hospital

Support, Scrotal, Therapeutic

General Hospital

Whole Room Microbial Reduction Device

General Hospital

Detectors And Removers, Lice, (Including Combs)

General Hospital

Accessories To Examination Light

General Hospital

Stocking, Medical Support (For General Medical Purposes)

General Hospital

Blood Borne Pathogen Response Kit

General Hospital

Strip, Temperature, Forehead, Liquid Crystal

General Hospital

Pump, Infusion, Pca

General Hospital

Saline Vascular Access Flush With Integrated Alcohol Disinfectant Device

General Hospital

Stationary Infrared Thermometer

General Hospital

Depressor, Tongue, Non-Surgical

General Hospital

Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs

General Hospital

Low Dead Space Needle, Single Lumen, Hypodermic

General Hospital

Warmer, Infant Radiant

General Hospital

Tubing, Noninvasive

General Hospital

Administrations Sets With Neuraxial Connectors

General Hospital

Stapler, Surgical

General Hospital

Warmer, Thermal, Infusion Fluid

General Hospital

Rigid Sterilization Container With Software

General Hospital

Lubricant, Vaginal, Patient

General Hospital

Sterilizer, Steam

General Hospital

Mattress, Water, Temperature Regulated

General Hospital

Heparin Flush In 0.45% Sodium Chloride

General Hospital

Powder-Free Guayle Rubber Examination Glove

General Hospital

Thermometer Kit

General Hospital

Automated Endoscope Channel Cleaner

General Hospital

Cover, Mattress (Medical Purposes)

General Hospital

Fall Prevention Alarm/Sensor Attached Only

General Hospital

Rfid Chip For Dental Appliance

General Hospital

Bed, Manual

General Hospital

Indicator, Biological, Liquid Chemical Sterilization Process

General Hospital

Mid-Stream Collection Kit

General Hospital

Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days

General Hospital

Central Venous Catheter Dressing Change Kit

General Hospital

Bottle, Hot/Cold Water

General Hospital

Chamber, Reverse Isolation, Patient Care

General Hospital

Peripheral Catheter Insertion Kit

General Hospital

Kit, Chemical Snake-Bite

General Hospital

Body Temperature Sensing Software

General Hospital

Image Processing Device For Estimation Of External Blood Loss

General Hospital

Lubricant, Patient

General Hospital

Oral Lubricant

General Hospital

Implantable Radio Frequency Transponder System

General Hospital

Water, Vascular Access Flush

General Hospital

Buret Administration Intravenous Kit

General Hospital

Allergen And Vaccine Delivery Needles

General Hospital

Bed, Ac-Powered Adjustable Hospital

General Hospital

Mattress And Bed Deck Cover (Medical Purposes)

General Hospital

Unit, Neonatal Phototherapy

General Hospital

Infant Positioner, Rx, Use In Highly Monitored Setting

General Hospital