MalfunctionJQW

STAR COMPL. WITH ACCESSORIES

Received Jun 18, 2026 · Event occurred May 26, 2026

Report 2243471-2026-02435 · MDR key 25549546

Device

Generic name

Station, Pipetting And Diluting, For Clinical Use

Manufacturer

Roche Molecular Systems, Inc. - Branchburg

Catalog number

04640535001

Product problems

Misfocusing

Patient

Not reported

No Clinical Signs, Symptoms or Conditions

Narrative

Additional Manufacturer Narrative

INVESTIGATION IS ONGOING.

Description of Event or Problem

THERE WAS AN ALLEGATION OF A MISREADING OF A SAMPLE BARCODE WHEN USING THE HAMILTON STAR COMPL. WITH ACCESSORIES. IT WAS OBSERVED THAT THE SAMPLE BARCODE ID (B)(6) WAS INCORRECTLY CAPTURED AS "90".