On (b)(6) 2021, a service engineer (fse) was dispatched to the customer for evaluation/repair.Several actions were done : vacuum adjustment, and a change of syringe, washwell, and tube z3.The fse also found cuvette balls lying around.On (b)(6) 2021, the fse was dispatched again; the fse changed the cap piercing needle, the pinch valve, the piercing mechanism, and the block of 3 electrovalves.The instrument data files have been collected and the analysis is ongoing.A follow-up report will be sent once the investigation is complete.The stago reference complaint is (b)(4).
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Four erroneous ufh results with sta liquid anti-xa reagent on sta compact max analyzer were reported.All of them were falsely <0.1 iu / ml results (absence of heparin).On (b)(6) 2021 : results <0.1 iu / ml.Then, tests reran the same day on another instrument: patient 1: released at 0.51 iu / ml.Patient 2: released at 1.11 iu / ml.Patients 1 & 2 have received a change in the therapy but no serious injury was reported.On (b)(6) 2021: results <0.1 iu / ml.Then, tests reran 30min later on the same instrument: patient 3: released at 0.33 iu / ml.Patient 4: released at 0.21 iu / ml.No information about any changes in treatment for these patients.No serious injury to our knowledge.The internal quality controls were within acceptable ranges before and after the events.
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