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Luminex Corporation Recall 90122

Description: VERIGENE Enteric Pathogens Nucleic Acid Test, Part No. 30-002-23

Luminex Corporation Recall 90122 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-1335-2022
Event ID90122
Event DescriptionVERIGENE Enteric Pathogens Nucleic Acid Test, Part No. 30-002-23
Product TypeDevices
DistributionWorldwide distribution - US Nationwide and the countries of Kuwait, Austria, France, Greece, Kuwait, Turkey.
Quantity5601 units
Recall ReasonThere is a potential for false negative results using VERIGENE CDF Stool PREP KIT and VERIGENE EP Stool PREP KIT due to hydrophobic characteristics of the swab.
Device Classification20220713
Device Code InfoUDI 00840487101568 Luminex Lot Number 030121023A, FLOQSwab Lot Number: 2100856; Luminex Lot Number 030221023D, FLOQSwab Lot Number: 2100856; Luminex Lot Number 030221023E, FLOQSwab Lot Number: 2100856; Luminex Lot Number 030221023F, FLOQSwab Lot Number: 2100856; Luminex Lot Number 030821023A, FLOQSwab Lot Number: 2100856; Luminex Lot Number 030921023D, FLOQSwab Lot Number: 2100856; Luminex Lot Number 031021023E, FLOQSwab Lot Number: 2100856; Luminex Lot Number 031621023D, FLOQSwab Lot Number: 2100856; Luminex Lot Number 031721023D, FLOQSwab Lot Number: 2100856; Luminex Lot Number 032221023A, FLOQSwab Lot Number: 2032870; Luminex Lot Number 032421023E, FLOQSwab Lot Number: 2032870; Luminex Lot Number 032521023E, FLOQSwab Lot Number: 2100856; Luminex Lot Number 033021023E, FLOQSwab Lot Number: 2100856; Luminex Lot Number 041421023F, FLOQSwab Lot Number: 2100856; Luminex Lot Number 050521023H, FLOQSwab Lot Number: 2100856; Luminex Lot Number 050621023C, FLOQSwab Lot Number: 2032870; Luminex Lot Number 051221023E, FLOQSwab Lot Number: 2100856; Luminex Lot Number 051221023F, FLOQSwab Lot Number: 2100856, 2032870; Luminex Lot Number 051721023B, FLOQSwab Lot Number: 2100856, 2032870; Luminex Lot Number 052721023D, FLOQSwab Lot Number: 2107946; Luminex Lot Number 060121023A, FLOQSwab Lot Number: 2107946; Luminex Lot Number 060921023C, FLOQSwab Lot Number: 2032870; Luminex Lot Number 062321023E, FLOQSwab Lot Number: 2107946; Luminex Lot Number 062921023D, FLOQSwab Lot Number: 2107946; Luminex Lot Number 063021023D, FLOQSwab Lot Number: 2110850; Luminex Lot Number 063021023E, FLOQSwab Lot Number: 2107946; Luminex Lot Number 070121023D, FLOQSwab Lot Number: 2107946; Luminex Lot Number 070621023A, FLOQSwab Lot Number: 2107946; Luminex Lot Number 070821023G, FLOQSwab Lot Number: 2107946; Luminex Lot Number 070821023H, FLOQSwab Lot Number: 2107946; Luminex Lot Number 080321023C, FLOQSwab Lot Number: 2107946; Luminex Lot Number 081621023D, FLOQSwab Lot Number: 2110850; Luminex Lot Number 081721023F, FLOQSwab Lot Number: 2107946, 2110850; Luminex Lot Number 081721023G, FLOQSwab Lot Number: 2110850; Luminex Lot Number 081921023D, FLOQSwab Lot Number: 2110850; Luminex Lot Number 082021023D, FLOQSwab Lot Number: 2100856; Luminex Lot Number 082021023E, FLOQSwab Lot Number: 2110850; Luminex Lot Number 082521023D, FLOQSwab Lot Number: 2100856, 2110850; Luminex Lot Number 082621023D, FLOQSwab Lot Number: 2110850; Luminex Lot Number 083121023D, FLOQSwab Lot Number: 2110850; Luminex Lot Number 090821023D, FLOQSwab Lot Number: 2100856; Luminex Lot Number 091521023D, FLOQSwab Lot Number: 2032870; Luminex Lot Number 091621023D, FLOQSwab Lot Number: 2100856; Luminex Lot Number 091621023G, FLOQSwab Lot Number: 2110850; Luminex Lot Number 092721023A, FLOQSwab Lot Number: 2110850; Luminex Lot Number 092821023E, FLOQSwab Lot Number: 2110850; Luminex Lot Number 092921023E, FLOQSwab Lot Number: 2110850; Luminex Lot Number 100621023C, FLOQSwab Lot Number: 2110850; Luminex Lot Number 101221023D, FLOQSwab Lot Number: 2110850; Luminex Lot Number 101321023D, FLOQSwab Lot Number: 2110850; Luminex Lot Number 101921023G, FLOQSwab Lot Number: 2110850; Luminex Lot Number 102021023E, FLOQSwab Lot Number: 2107946, 2110850; Luminex Lot Number 102221023D, FLOQSwab Lot Number: 2110850; Luminex Lot Number 102821023F, FLOQSwab Lot Number: 2107946.
Center Classification Date20220706
Recall Initiation Date20220617
Recalling FirmLuminex Corporation
Initial Notification Letter
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