Biomerieux Inc recalls VITEK 2 Gram-negative Susceptibility Cards Containing o Polymyxin B (pb02n) o Ceftazidime/avibactam (cza02n) o Meropenem/Vaborbactam…
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…
Read the official notice →- Date
- 2026-02-11
- Country
- United States
- Brand
- Biomerieux
- Product
- VITEK 2 Gram-negative Susceptibility Cards Containing o Polymyxin B (pb02n) o Ceftazidime/avibactam (cza02n) o Meropenem/Vaborbactam…
- Classification
- Class II
- Units
- Worldwide - US Nationwide distribution.
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2026-09-30
USBiomerieux Inc recalls VITEK 2 AST-N461 TEST KIT, GRAM NEGATIVE SUSCEPTIBILITY TESTING - AUTOMATED, Reference Number 424811
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 risk of false resistant results. False…
FDA · DeviceBiomerieux IncInternational distribution to the countries of Austria, Germany, Luxembourg.Official notice →- 2026-07-15
- US
Biomerieux 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 → - 2025-10-08
- US
bioMerieux, Inc. recalls VITEK¿ 2 Gram-negative AST Test Kits (Cards) containing Colistin formulation cs02n. VITEK¿ 2 is an automated system consisting of…
Potential for false resistant results for Colistin (cs02n) with multi-drug-resistant Pseudomonas aeruginosa and Acinetobacter baumannii complex used in specific cards
FDA · DevicebioMerieux, Inc.International distribution in the countries of Albania, Armenia, Australia,…Official notice → - 2024-05-01
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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…
- 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…
For users with MYLA V4.8.X / V4.9 that use VITEK MS to identify organisms as part of their workflow, AST filter rules that have been activated are not always being applied to AST results when sending the results to the…
FDA · DeviceBiomerieux IncUS Nationwide distribution to the states of Alabama, California, North…Official notice → - 2023-01-11
- US
Biomerieux Inc recalls PPM LOMBARD PRODUCTS TSA 10PLT, CATALOG M1040
As the temperature and time out of range was exceeded, product performances cannot be guaranteed
Other drugs & medical recalls in the United States
- 2026-02-11
- US
Siemens Medical Solutions USA, Inc recalls NAEOTOM Alpha.Pro Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS
To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.
FDA · DeviceSiemens Medical Solutions USA, IncWorldwide distribution - US Nationwide and the countries of Canada, Costa…Official notice → - US
Medtronic MiniMed, Inc. recalls MiniMed 780G Insulin Pump Catalog Numbers: MMT-1884 MMT-1886 With Software Version 6.60 The MiniMed 780G insulin pump is indicated for…
A software timing and processor communication issue in MiniMed" 780G software version 6.60 may trigger Pump Error 43 and/or Pump Error 41, resulting in suspension of insulin delivery.
FDA · DeviceMedtronic MiniMed, Inc.Worldwide - U.S. National distribution including in the states of AL, AR, AZ,…Official notice → - US
Tornier, Inc recalls TORNIER PERFORM REVERSED PERIP SCREW 5.0MMX18MM NON STERILE, catalog number DWJ318
A specific lot of screws is incorrectly labeled. Screws are labeled as 5.0mmx18mm but actual screws are 5.00mmx14mm. If mismatch is detected during surgery, the issue may cause a minor delay in surgery. If not detected…
- US
Beckman Coulter, Inc. recalls CellMek SPS Sample Preparation System, REF: C44603, with software
Sample preparation system designed to automate staining, lysing, cell washing has a software error that causes samples to be dispensed close to or touching tube bottoms, which could dislodge fluid line, result in…
FDA · DeviceBeckman Coulter, Inc.Worldwide - US Nationwide distribution in the states of MO, WA, MA, IL, AL,…Official notice → - US
Encore Medical, LP recalls EMPOWR 3D Knee Tibial Insert 5R 14MM, VE, REF: 342-14-705
942-01-40G acetabular system package was found to contain 942-01-36H acetabular system; and several other acetabular system and knee insert devices may also have a packaging discrepancy, which may cause surgical delay…
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Intuitive Surgical, Inc. recalls Brand Name: Da Vinci Product Name: da Vinci X, Xi Surgical System, & da Vinci 5 Surgical System Model/Catalog Number: IS4000; IS4200;…
Due to a software implementation error that allowed instruments arms failing an important diagnostic test to remain in clinical use. This test was supposed to be used to detect Universal Surgical Manipulator insertion…
FDA · DeviceIntuitive Surgical, Inc.U.S.: AL, AR, CA, CO, CT, FL, ID, IL, IN, KS, KY, MD, MI, MN, MS, MO, NC, NJ,…Official notice →