Luminex Corporation: Medical Device Recalls in 2019

According to to data from the FDA, there were 9 medical device recalls made by Luminex Corporation in 2019. See the details of the recalls below.

You can see similar recalls for other firms.

• Vergene Amplification Tray - 700uL, BC-GP REF 20-011-018 The Verigene(R) Gram-Positive Blood Culture Nucleic Acid Test (BC-GP) performed using the sample-to-result Verigene System is a qualitative, multiplexed in vitro diagnostic test for the simultaneous detection and identification of potentially pathogenic gram-positive bacteria which may cause bloodstream infection (BSI). BC-GP is performed directly on blood culture bottles identified as positive by a continuous monitoring blood culture system and which contain gram-positive bacteria.
• Aries Bordetella Assay, REF 50-10037, UDI # 00840487101452
• ARIES Extraction Kit; ARIES System; SYNCT , REF 50-10026, UDI # 00840487100073
• ARIES C. difficile Assay , REF 50-10018, UDI # 00840487100059
• ARIES HSV 1&2 Assay , REF 50-10017, UDI # 00840487100295
• ARIES Flu A/B & RSV Assay , REF 50-10020, UDI # 00840487100158
• ARIES GBS Assay , REF 50-10021, UDI # 00840487100165
• Luminex Aries M1 System Model: Aries M6V1 Aries Software v1.0 For In Vitro Diagnostic Use in clinical laboratories. Scanner Label/Labeling: JADAK JDK-2330 REV B 170512-017
• ARIES Group A Strep Assay , REF 50-10041, UDI # 00840487101469