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…
Read the official notice →- Date
- 2023-03-08
- Country
- United States
- Brand
- Biomerieux
- Product
- MYLA comprises AST Filters in conjunction with VITEK MS; middleware which connects microbiology laboratory instruments for ID/AST and…
- Classification
- Class II
- Units
- US Nationwide distribution to the states of Alabama, California, North…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
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
- 2026-02-11
USBiomerieux 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…
- 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…
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…
- 2023-01-11
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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
- 2022-10-05
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bioMerieux, Inc. recalls VIDAS CMV IgM, 30 tests, REF 30205-01, IVD, Rx.
Invalid calibrations (out of range high) while using the product.
FDA · DevicebioMerieux, Inc.Distribution was made to CA, FL, GA, IL, IN, LA, MA, MD, ME, MO, NJ, NY, OH,…Official notice → - 2022-09-07
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bioMerieux, Inc. recalls VITEK 2 / MYLA VITEK 2 Software versions 8.01, 8.02 (veterinary use only), 9.01, 9.02, 9.03 MYLA Software versions V4.8 and V4.9
There are 7 reported software anomalies that may affect use of the device.
FDA · DevicebioMerieux, Inc.International distribution to the countries of Estonia, Bahrain, Pakistan, UK,…Official notice →
Other drugs & medical recalls in the United States
- 2023-03-08
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Carestream Health, Inc. recalls DRX-Compass/DR-FIT X-ray Systems with Firmware version 2.3.2.0/2.3.2.4. For use in obtaining diagnostic quality radiographic images to…
After pressing and releasing the Z-Axis Motorized buttons on the Tube Head Display, the Overhead Tube Crane (OTC) could potentially continue the movement unexpectedly to a certain distance which could potentially…
FDA · DeviceCarestream Health, Inc.Worldwide distribution - US Nationwide distribution in the states of…Official notice → - US
Med-Mizer, Inc. recalls Sit to Stand STS500 Patient Lift
Risk of boom pivot failing due to the nut securing the boom becoming loose and the bolt to be unsecure to the flange on the side.
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SEDECAL SA recalls Phoenix mKDR Xpress, digital mobile diagnostic x-ray system
Sedecal was informed of 3 incidents of erratic movements related to X-ray mobile systems.
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Beaver Visitec International, Inc. recalls Ultracell Wick with 80cc Collection Bag, 20/box
Device packaging may contain open seals, compromising product sterility.
FDA · DeviceBeaver Visitec International, Inc.US distribution in AL, CA, CO, DC, FL, GA, IL, LA, MD, MN, MT, NC, NH, NJ, NM,…Official notice → - US
CooperVision, Inc. recalls Biofinity XR Toric 6-pack- Soft (hydrophilic) Contact Lens (extended wear)
Manufactured with misaligned axis resulting in lenses with the incorrect power, users may experience poor visual acuity
FDA · DeviceCooperVision, Inc.US Nationwide distribution in the states of CA, OH, NC, PA.Official notice → - US
Unetixs Vascular, Inc. recalls MultiLab Series II ROODRA non-invasive vascular diagnostic device, Model Number 11986-0000-01
The current luer fittings and adaptors allow for the possibility of the air line to be misconnected to an intravenous line, which may cause an air embolism.
FDA · DeviceUnetixs Vascular, Inc.Worldwide distribution - US Nationwide and Global distribution.Official notice →