Biomerieux Inc recalls API ID 32 C Strips, Reference 32200, Rx Only, IVD API ID 32 C is a qualitative standardized system for the identification of yeasts. It…
Risk of misidentification or delayed results with the absence of identification due to thermoforming defect.
Read the official notice →- Date
- 2022-02-02
- Country
- United States
- Brand
- Biomerieux
- Product
- API ID 32 C Strips, Reference 32200, Rx Only, IVD API ID 32 C is a qualitative standardized system for the identification of yeasts. It…
- Classification
- Class II
- Units
- US (Domestic) Distribution to states of: AZ, IA, KY, and NY.
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2022-09-07
USbioMerieux, 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 →- 2022-08-31
- US
bioMerieux, Inc. recalls NUCLISENS easyMAG Magnetic Silica, REF 280133, 24 x 1.2mL bottles/kit.
There is a potential of no result leading to possible delayed result due to contamination of extraction reagents.
FDA · DevicebioMerieux, Inc.Distribution was made to AR, AZ, CA, CT, FL, IL, IN, KS, KY, MA, MD, MI, MN,…Official notice → - 2022-05-18
- US
bioMerieux, Inc. recalls VITEK 2 Systems and VITEK 2 with MYLA.
Software issue where results sent to the LIS via HL7 format for antibiotic screen tests and synergy tests do not include the user-corrected or AES-corrected interpretation. This can potentially lead to incorrect final…
FDA · DevicebioMerieux, Inc.U.S. distribution of the FSCA to NC. OUS distribution of the FSCA to…Official notice → - 2022-01-05
- US
bioMerieux, Inc. recalls VIDAS RUB IgG (RBG), REF 30226
bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to potential delayed results as the user must run another test.
- US
Biomerieux Inc recalls RAPID 20 E, REF 20701, System for the identification of Enterobacteriaceae in 4 hours, 25 strips/package, IVD.
There is an error in the new version of the package insert. The Reading Table lists the incorrect color for a negative result for the CIT test.
FDA · DeviceBiomerieux IncUS Nationwide distribution in the states of AL, AZ, CA, CO, CT, DE, FL, GA,…Official notice → - 2021-11-24
- US
bioMerieux, Inc. recalls API 50 CH, Model 50300
There is potential to provide an incorrect organism identification.
Other drugs & medical recalls in the United States
- 2022-02-02
- US
NuVasive Specialized Orthopedics, Inc. recalls MAGEC 1 System
Safety Alert to all surgeons informing them of post-implantation fractures of an internal metallic component for device manufactured prior to March 26, 2015.
- US
Velano Vascular recalls PIVO Blood Collection Device 20G, REF: 202-0005
Incomplete sealing of blood collection device unit packages may produce a breach in the sterile barrier enclosing the product. This could lead to microbial contamination of the device prior to use. The health effects…
FDA · DeviceVelano VascularUS Nationwide distribution in the states of CT, CO, UT, PA, IL, WA, CA, NJ,…Official notice → - US
NRT X-RAY A/S recalls 1. Footrest ( use exclusively in combination with Intelli-C devices) 2. Shoulder support ( use exclusively in combination with Intelli-C…
Friction rubber block in the clamping mechanism was missing in the Footrest. It may slip down along the patient table while in use with a patient. This accessory is designed to use with Intelli-C, Right and Intelli-C,…
FDA · DeviceNRT X-RAY A/SUSA: IA, KY,LA, MA, NC,NY, OH, SC, WA, WV OUS: Switzerland, Czech Republic,…Official notice → - US
GE Healthcare, LLC recalls GE Vscan Extend, being sold as "Vscan Extend Sector DICOM"
The firm identified that the Vscan Extend device will not power on because of depleted battery, due to the device not being turned off prior to battery removal or when being connected to a computer without AC power.
FDA · DeviceGE Healthcare, LLCDomestic: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY,…Official notice → - US
Siemens Medical Solutions USA, Inc recalls Artis pheno with software VE20C- diagnostic imaging angiography system Model: 10849000
Four potential software issues with Artis pheno and Artis icono systems with software VE20C: 1. Updated calibration data not saved with measurement after scene+/-; 2. No x-ray possible, system shutdown/restart might be…
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Philips Respironics, Inc. recalls Trilogy Evo, Material Numbers DS2110X11B (USA) and KR2110X15B (Korea) The Trilogy Evo ventilator provides continuous or intermittent…
Philips has identified a specific lot of non-conforming material manufactured by one of its suppliers. A Philips supplier incorrectly used polyester-based polyurethane (PE-PUR) sound abatement foam, a non-conforming…
FDA · DevicePhilips Respironics, Inc.Worldwide Distribution: Distributed to the following US states: AR, CO, FL,…Official notice →