COBAS TaqMan Mycobacteria tuberculosis (MTB) Test FOR IN VITRO DIAGNOSTIC USE.
Check against the official notice below — it lists the full affected range.
Roche Molecular Systems has recalled the COBAS TaqMan Mycobacteria tuberculosis (MTB) Test due to an incorrect Target Elbow Max cutoff value of 48 in the Test Definition Files (TDF) v3.0. This defect affects both CE-IVD and JPN-IVD versions of the test when used with AMPLILINK software version 3.3 series and corresponding test kits. The problem creates the potential for false negative results in patient samples with Target Elbows in the range of 48 to 50. The affected products have been distributed worldwide to 22 European Union countries, 41 additional countries, and Japan, with a total of 335 CE-IVD TDFs and 48 JPN-IVD TDFs involved.
The recalled test kits and definition files are identified by specific material numbers: CE-IVD Kit (04803531190) and TDF (05574455190), and JPN-IVD Kit (04653360190) and TDF (05574447190), with all lot and serial numbers affected. The source document does not specify a remedy or course of action for affected consumers.
Written by software from the official notice below. Not reviewed by a lawyer.
The COBAS TaqMan MTB Test Definition Files (TDF) v3.0, for both CE-IVD and JPN-IVD tests, being used with AMPLILINK software version 3.3 series and COBAS TaqMan MTB Test Kits, both CE-IVD and JPN-IVD, have an incorrect Target Elbow Max cutoff value of 48 creating the potential for false negative results to be generated for patient samples with Target Elbows in the range of 48 to 50.
Reason for recall: The COBAS TaqMan MTB Test Definition Files (TDF) v3.0, for both CE-IVD and JPN-IVD tests, being used with AMPLILINK software version 3.3 series and COBAS TaqMan MTB Test Kits, both CE-IVD and JPN-IVD, have an incorrect Target Elbow Max cutoff value of 48 creating the potential for false negative results to be generated for patient samples with Target Elbows in the range of 48 to 50. Distribution: Worldwide Distribution - Foreign (22 EU countries - Austria, Belgium, Bulgaria, Croatia, Cypress, Czech Republic, Denmark, Germany, Finland, France, Greenland, Hungary, Iceland, Italy, Luxembourg, Netherland, Norway, Sweden, Switzerland, Spain, Turkey, UK); (41 Rest of World countries - See Attachment for full country distribution + Japan, Portugal and Mexico) Quantity: 335 CE-IVD TDFs; 48 JPN-IVD TDFs Lot/code info: Material Number: CE-IVD: 04803531190 Kit, 05574455190 TDF; JPN-IVD: 04653360190 Kit, 05574447190 TDF. Lot/Serial Number: CE-IVD: All Kits, JPN-IVD: All Kits.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.