Luminex recalls VERIGENE Blood Culture Gram-Positive Nucleic Acid Kits (five-pack carriers) due to potential false negative results in bacterial detection tests. Affected units include specific supplier and utility tray lots.
Potential to lead to a false negative results.
Luminex is recalling VERIGENE Blood Culture Gram-Positive Nucleic Acid Kits (five-pack carriers) because they may cause false negative results in bacterial detection tests. This could lead to incorrect diagnoses and treatment decisions if the kits are used without the recall fix.
The kits may produce false negative results, meaning they could fail to detect gram-positive bacteria when present. This might lead to incorrect diagnoses and inappropriate treatment decisions if the kits are used without the recall fix.
Healthcare professionals using these kits for in vitro diagnostic testing are most likely affected. Patients relying on accurate bacterial detection results could be impacted if the kits produce false negatives.
Check for the product name 'VERIGENE Blood Culture Gram-Positive Nucleic Acid Kits' packaged as five-pack carriers. Affected units include supplier raw tray lots 195916-070518, 190943-073118 and utility tray lots 082518018C, 081618018C, 082918018C, 090418018B, 081118018C, and 082718018B.
Compare your kit's lot numbers with the listed affected lots: supplier raw tray lots 195916-070518 and 190943-073118, and utility tray lots 082518018C, 081618018C, 082918018C, 090418018B, 081118018C, and 082718018B.
The recall is due to potential false negative results, not immediate safety hazards. Kits with unaffected lot numbers should be safe for use.
Check your kit's supplier raw tray lot and utility tray lot numbers against the listed affected lots: 195916-070518, 190943-073118, 082518018C, 081618018C, 082918018C, 090418018B, 081118018C, and 082718018B.
The recall does not specify a remedy, so affected kits should be checked against the list and handled with caution until a replacement or fix is available.
We’ve drafted a message you can send Luminex to request your refund or repair — edit it as you like.
Subject: Recall Z-0445-2019 — Luminex Luminex Hello, I own a Luminex that is covered by recall Z-0445-2019 from Luminex. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
