Biomerieux Inc recalls VITEK 2 - AST Test kits (in vitro diagnostic test cards for antimicrobial susceptibility): a) AST-N334, REF 418984; b) AST-GN95, REF…
Ceftriaxone (cro02n) concentration errors associated with specific recently manufactured test kits which would have the potential for for false susceptible results. The risk is present for isolates that have a result…
Read the official notice →- Date
- 2024-05-01
- Country
- United States
- Brand
- Biomerieux
- Product
- VITEK 2 - AST Test kits (in vitro diagnostic test cards for antimicrobial susceptibility): a) AST-N334, REF 418984; b) AST-GN95, REF…
- Classification
- Class I
- Units
- Worldwide
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
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- Check the product name, strength and lot number against the official notice.
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General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More Biomerieux recalls
- 2026-07-15
USBiomerieux Inc recalls VITEK 2 AST-N447 TEST KIT Product reference 424620
Potential for false resistant carbapenem and/or cephalosporin results when analyzing samples with kits from affected lot that have pouch foil fractures.
FDA · DeviceBiomerieux IncInternational distribution to the countries of Belgium and the Netherlands.Official notice →- 2026-02-11
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Potential risk of Quality Control failures and/or false resistant antibiotic results when testing isolates of Enterobacterales/Enterobacteriaceae species and/or Pseudomonas aeruginosa with the identified antibiotic…
- 2025-10-08
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bioMerieux, Inc. recalls VITEK¿ 2 Gram-negative AST Test Kits (Cards) containing Colistin formulation cs02n. VITEK¿ 2 is an automated system consisting of…
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FDA · DevicebioMerieux, Inc.International distribution in the countries of Albania, Armenia, Australia,…Official notice → - 2023-03-08
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Biomerieux Inc recalls MYLA comprises AST Filters in conjunction with VITEK MS; middleware which connects microbiology laboratory instruments for ID/AST and…
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FDA · DeviceBiomerieux IncUS Nationwide distribution to the states of Alabama, California, North…Official notice → - 2023-01-11
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As the temperature and time out of range was exceeded, product performances cannot be guaranteed
- 2022-10-05
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Invalid calibrations (out of range high) while using the product.
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Other drugs & medical recalls in the United States
- 2024-05-01
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Ion Beam Applications S.A. recalls IBA Proton Therapy System - PROTEUS 235, PTS-10 versions, PTS-11 versions, and PTS-12 versions.
There is a risk of mistreatment as irradiation is not prevented when some safety parameters are out of tolerance.
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Abbott Molecular, Inc. recalls Alinity m System, Part Number: 08N53-002
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FDA · DeviceAbbott Molecular, Inc.Worldwide distribution - US Nationwide and the countries ARGENTINA, AUSTRALIA,…Official notice → - US
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FDA · DeviceSiemens Medical Solutions USA, Inc.Worldwide distribution - US Nationwide including in the states of AL, AR, CA,…Official notice → - US
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