Qiagen

Identified faulty cartridges. If such a faulty cartridge is used for sample testing, false test results could occur.

Heater shaker module does not perform heating if the temperature is set below 40C for static incubation steps when running IVD protocol QIAamp DSP DNA Mini Kit (cat. no. 61304), Protocol: Isolation of genomic DNA from Gram-positive bacteria (Script filename: Kt_name_Bacteria (Gram+) or rY'east_Enzymatic Lysis_ V2) which could potentially cause delayed or erroneous results depending on the downstream assay.

Insufficient welding leads to the heater cable becoming brittle and present with an error: ERROR 3481 HEATER UNABLE TO REACH TEMPERATURE; the instrument may stop, and the sample being processed will be lost

Handbook Revision (Rev13) a dilution step is indicated as an Action when having the Flag SAMPLE_INT_CTRL_FAIL. A dilution of CRC tissue could lead to a false negative result. To remove ambiguity, an alteration must be made to the S the sample result with this flag should be interpreted as invalid

Identified a decreased performance reliability rate, Run abortions could cause delayed diagnosis since sample testing would have to be repeated

Identified a decreased performance reliability rate, Run abortions could cause delayed diagnosis since sample testing would have to be repeated

If cartridges of the affected Serial numbers (SNs) are used, in most cases, the error codes 0xY0003EA and 0xY00045A (where Y is a number between 1 and 4) that lead to a run abortion will occur and no results will be reported

Faulty cartridges in the lot could result in false test results.

Kit lots contain a small percentage of damaged Filter-Tips that are leaking when being used with the QIAsymphony SP/AS Instruments (REF 9001297 and 9001301)

Potential for control line not appearing on the test strip