Every recall we track for Roche Diagnostics Corporation — 33 in all — plus the complaints and injury reports the public filed about them.
Roche recalls Tina-quant lgA Gen. 2 blood tests due to calibration failures from reagent contamination. Affected lots include 368756. Stop using if you have this test kit.
Roche recalls cobas p 701 post-analytical units (serials 1001-1037, 502) due to risk of tray flap detaching. This could cause sample damage or instrument malfunction.
Roche recalls cobas p 501 post-analytical units (serial 1001-1044) due to risk of tray flap detaching. This could cause sample damage or instrument malfunction.
Roche recalls Albumin BCP test kits due to calibration failures causing inaccurate albumin measurements. Affected lots may lead to incorrect test results for serum and plasma analysis.
Roche recalls cobas e 801 immunoassay analyzers after complaints of signal drops during bottle changes, which could lead to incorrect medical decisions. Affected units may need repair or replacement.
Roche recalls Cobas Infinity software versions 2.0-2.5 for potential QC alarm failures when switching bottles in clinical lab use. Affected units include specific serial numbers and material numbers.
Roche recalls Tina-quant IgM Gen.2 test kits with specific catalog numbers due to potential interference issues that could affect lab test accuracy. Affected users should contact Roche for guidance.
Roche recalls Anti-HAV IgM test system with material no. 11820591160 due to potential for erroneous results when used on cobas e 602 analyzers. Affected units may show incorrect hepatitis A infection results.
Roche recalls Bilirubin Total Gen.3 test kits (model numbers 05795397190, 05795419190, 05795320160, 05795338160, 05795346160) due to potential incorrect bilirubin results on certain analyzers, which could affect medical decisions.
Roche recalls Lactate Gen.2 test kits (catalog numbers 03183700190, 05171881190, 11822837190) that may cause inaccurate blood lactate results on certain analyzers, posing medical risks.
Roche recalls cobas c 111 analyzers used for creatinine and triglyceride tests due to carry-over risk. Affected units may need extra wash cycles or batch mode for accurate results.
Roche recalls COBAS INTEGRA 400 plus analyzers used in specific lipid tests due to potential carry-over errors affecting results. Affected units include Tina-quant Apolipoprotein A-1 ver.2 and other assays with catalog numbers listed.
Roche recalls URISYS 1100 urine analyzers with specific part numbers due to potential false negatives for protein, nitrite, leukocytes, and erythrocytes. Affected units may not detect these substances correctly.
Roche recalls CoaguChek XS PT test strips with catalog numbers 04625315160, 04625374160, and 07797826160 due to abnormally high INR test results. Affected lots listed in the recall notice.
Roche recalls cobas p 612 pre-analytical systems (model 07563116001) due to potential contamination causing false positive test results. All units are affected.
Roche recalls Vitamin D test system that may give false high results, risking vitamin D deficiency if dosage is reduced. Affected users should check if they have the specific material number.
Roche recalls Vitamin D test system that may give falsely high results, risking vitamin D deficiency if users adjust doses without proper monitoring. Affected units sold with specific analyzers.
Roche recalls cobas e 801 and cobas 8000 Modular Series analyzers due to potential plunger cracking causing impaired syringe function. Affected units have specific serial numbers.
Roche recalls Omni S Analyzer models 3337138001 and 3337138692 due to software failure preventing scheduled AutoQC measurements. Affected units may not properly check instrument calibration.
Roche recalls Omni S6 analyzers with catalog numbers 3337154001 and 3337154692 due to software failure preventing scheduled AutoQC measurements. This may affect lab accuracy.
Roche recalls Omni S2 analyzers with catalog numbers 3337111001 and 3337111692 due to software failure preventing scheduled AutoQC measurements from activating.
Roche recalls Omni S Analyzer AutoQC Module Complete (catalogs 3313522001, 3313522692) due to software failure preventing scheduled quality control tests. This may affect test accuracy in critical care labs.
Roche recalls specific acetaminophen test kits due to rare risk of unreliable results from certain blood conditions. Affected lots from 2016-2018 may need replacement.
Roche recalls Elecs: BRAHMS PCT Immunoassay due to decreased patient sample recovery on certain analyzers. This may affect lab results accuracy. Affected units include specific lot numbers.
Roche recalls Modular E 170 analyzers that may give questionable results when using 13mm test tubes without adapters. Affected units have specific catalog numbers.
Roche recalls cobas e 411 analyzers with specific catalog numbers due to questionable test results when using 13mm sample tubes without adapters.
Roche recalls cobas e 601 modules for clinical use due to potential inaccurate test results when 13 sample tubes are used without adapters.
