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LSGN
Affinity Biosensors, LLC · Model LS6503 · UDI-DI 00860012092116
1
510(k) clearances
3,851
Adverse events (6 deaths)
238
Recalls
23
Facilities
Description
LifeScale Gram Negative Kit (LSGN) is used with the LifeScale AST system for testing positive blood culture samples containing gram-negative bacilli.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-07-24 | Biomerieux Inc | The issue is related to card pouch damage associated with a portion of the lot which was produced on a specific card pouching device, in a specific timeframe, causing a potential r |
| 2026-06-26 | Beckman Coulter Inc. | Analyzers contain incorrect algorithms which may affect antimicrobial susceptibility test results, leading to false susceptibility classifications." |
| 2026-06-26 | Beckman Coulter Inc. | Analyzers contain incorrect algorithms which may affect antimicrobial susceptibility test results, leading to false susceptibility classifications." |
| 2026-06-04 | Biomerieux Inc | Potential for false resistant carbapenem and/or cephalosporin results when analyzing samples with kits from affected lot that have pouch foil fractures. |
| 2025-09-23 | Becton Dickinson & Co. | Product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials ar |
| 2025-06-26 | bioMerieux, Inc. | Potential for false resistant results for Colistin (cs02n) with multi-drug-resistant Pseudomonas aeruginosa and Acinetobacter baumannii complex used in specific cards |
| 2024-10-31 | Becton Dickinson & Co. | BD confirmed that product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product serv |
| 2024-08-01 | Becton Dickinson & Co. | Escherichia coli (E. coli) misidentification for clinical samples that were tested on BD Phoenix" M50 instrument and BD Phoenix" 100, may lead to misdiagnosis and inappropriate tre |
| 2024-08-01 | Becton Dickinson & Co. | Escherichia coli (E. coli) misidentification for clinical samples that were tested on BD Phoenix" M50 instrument and BD Phoenix" 100, may lead to misdiagnosis and inappropriate tre |
| 2024-03-14 | Biomerieux Inc | Ceftriaxone (cro02n) concentration errors associated with specific recently manufactured test kits which would have the potential for for false susceptible results. The risk is pr |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.