Every recall we track for Diagnostica Stago, Inc. — 23 in all — plus the complaints and injury reports the public filed about them.
Stago recalls STA Liatest D-Di kits with REF 00515 due to potential positive bias in D-dimer measurements, which could lead to inaccurate blood test results.
Diagnostica Stago recalls STA Liatest Free Protein S kits (model 00516) due to potential out-of-range results and underestimation of free protein S levels in patient plasmas. Affected kits may give incorrect readings for normal-range values.
Diagnostica Stago recalls Asserachrom HPIA kit model 00615 with lot 271288 due to potential false negative results in heparin-induced thrombocytopenia testing. Affected kits may not detect anti-heparin-platelet factor 4 antibodies correctly.
Diagnostica Stago recalls STA Liatest D-Di test kits with specific lot numbers due to potential underestimation of D-Dimer levels. Affected users should check their lot numbers and contact the manufacturer for guidance.
Stago recalls STA-Fibrinogen 5 kit (model 00674) due to potential contamination of anticoagulant reagents in UFH and LMWH treatments. Affected users should contact Stago for guidance.
Stago recalls STA-Liquid Anti-Xa 8 kits (model 00322US) due to potential contamination with fibrinogen reagents in heparin tests. Affected users should contact Stago for details.
Stago recalls all STA Satellite blood analyzers due to potential contamination of anti-Xa tests with fibrinogen reagents. Affected units may cause inaccurate blood test results.
Stago recalls STA-Liquid Anti-Xa 4 kits (model 00311US) due to potential contamination with fibrinogen reagents in heparin tests. Affected users should contact Stago for details.
Diagnostica Stago recalls Owren Koller buffer solution (model 00360) due to potential shorter clotting times in tests, which could overestimate results by up to 1%. Affected units sold with specific UDI and lot numbers.
Diagnostica Stago recalls STA R Max clinical instruments with firmware bug causing inaccurate coagulation test results. Affected units have specific reference numbers and serials. Contact for remedy.
Diagnostica Stago recalls STA Compact Max analyzers with reference numbers 58602/58612 due to a firmware bug causing inconsistent coagulation test results. Affected units may show intermittent shortened coagulation times and error 13.
Diagnostica Stago recalls STA Compact Automated Multi-Parametric Analyzer with firmware bug causing inconsistent coagulation test results. Affected units have reference numbers 58602 or 58612.
Stago recalls STA Deficient VIII product code 00725 due to risk of false high factor VIII results from cross-contamination. Affected units include specific STA-R and STA Compact analyzers with listed product codes and software versions.
Diagnostica Stago recalls Unicalibrator (ref. 00675) due to positive bias in factor VIII/IX measurements compared to international standards, affecting lab results.
Diagnostica Stago recalls STA System Control N+P (ref. 00678) due to positive bias in factor VIII/IX testing compared to international standards. Affected lots may cause inaccurate blood test results.
Diagnostica Stago recalls Staclot LA test kits that may produce shortened results outside 15 seconds. Affected kits have lot numbers 251918 or 252751.
Diagnostica Stago recalls Staclot LA 20 test kits with reported shortened results. Affected lots may cause inaccurate lupus anticoagulant testing.
Diagnostica Stago recalls STA Noplastine CI Plus 10ml vials for potential prolonged prothrombin time due to QC values outside assigned ranges. Affected lots include 250791-252737 with specific expiration dates.
Diagnostica Stago recalls STA Noplastine CI 10ml vials for potential prothrombin time measurement errors. Affected units have QC values outside assigned ranges, requiring immediate action.
Diagnostica Stago recalls Neoplastine Cl Plus reagent vials with potential for prolonged prothrombin time (PT) due to homogeneity defect. Affected lots: 115080 (exp 01/2018) and 251241 (exp 01/2018).
Diagnostica Stago recalls Neoplastine Cl reagent vials with potential for prolonged prothrombin time (PT) due to homogeneity defects. Affected lots: 251064 (exp 09/2018) and 251725 (exp 02/2019).
Diagnostica Stago recalls Neoplastine Cl Plus (ref. 00375) due to reagent vials causing prolonged prothrombin time. Affected lots: 250080 (exp 02/2018), 251762 (exp 02/2019), 251940 (exp 12/2018).
Diagnostica Stago recalls Neoplastine Cl Plus reagent vials with confirmed defect causing prolonged prothrombin time (PT) readings. Affected lots expire 2018-2019. Stop using if you have these lots.
