Drugs & medicalClass II

Remel, Inc recalls Remel Haemophilus Test Medium (Agar) (150mm), 10/pk, REF R04033; and Remel Haemophilus Test Medium (Agar)(100mm), 10/pk, REF 01503. For In…

The test medium may not perform as intended.

Read the official notice →
Date
2023-07-05
Country
United States
Brand
Remel
Product
Remel Haemophilus Test Medium (Agar) (150mm), 10/pk, REF R04033; and Remel Haemophilus Test Medium (Agar)(100mm), 10/pk, REF 01503. For In…
Classification
Class II
Units
Distribution was made nationwide, including Puerto Rico. There was no foreign…
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 Details may be shortened or out of date; the official notice is the authoritative source.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

  1. Check the product name, strength and lot number against the official notice.
  2. Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
  3. 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 Remel recalls

  1. 2025-03-26
  2. US
    Drugs & medicalClass II

    Remel, Inc recalls Zebra Thermal Barcode Printer GX430t, Model no. YSW 1000 or YSW 2000, may have been sold as an optional accessory for Sensititre Aris HIQ…

    Power supply unit for Zebra Printers used with the device can potentially overheat or cause a fire hazard.

    FDA · DeviceRemel, IncDomestic distribution to AL, AZ, CA, FL, GA, IN, KS, KY, MD, MI, NE, NY, OH,…Official notice →
  3. 2025-02-26
  4. US
    Drugs & medicalClass II

    Remel, Inc recalls remel BLOOD AGAR EMB AGAR BIPLATE, REF R02041, QTY 100, for invitro diagnostic use

    Product may contain surface and subsurface contamination of Listeria monocytogenes which is typically visible immediately upon removal from the packaging, appearing on the blood side of the biplate.

    FDA · DeviceRemel, IncUS Nationwide distribution.Official notice →
  5. 2024-11-06
  6. US
    Drugs & medicalClass II

    Remel, Inc recalls remel BactiDrop Acridine Orange, REF 21502, 50 per package.

    A color change of the solution within the dropper can occur from orange-yellow to light yellow resulting in out-of-specification fluorescent stain results.

    FDA · DeviceRemel, IncDistribution was made to IL, IN, MN, NE, SD, TX, VA, and WA. There was…Official notice →
  7. 2023-09-20
  8. US
    Drugs & medicalClass II

    Remel, Inc recalls remel TODD HEWITT W. CNA (LIM BROTH), REF R064810; used to isolate Group B Streptococci form clinical specimens containing mixed bacterial…

    On lot of Todd Hewitt Broth w/CNA (LIM) may exhibit no recovery of target organism during customer QC testing or use with patient samples

    FDA · DeviceRemel, IncUS Nationwide DistributionOfficial notice →
  9. 2022-12-14
  10. US
    Drugs & medicalClass I

    Remel Inc recalls Thermo SCIENTIFIC, Sensititre STP6F, Gram Negative IVD AST

    An internal technical investigation has confirmed that Thermo Scientific" Gram Negative IVD AST Sensititre Plate may lead to false susceptible results for Proteae Tribe (including Proteus spp., Providencia spp.,…

    FDA · DeviceRemel IncUS Nationwide DistributionOfficial notice →
  11. 2022-03-16
  12. US
    Drugs & medicalClass II

    Remel Inc recalls Thermo Scientific Sensititre Gram Negative Susceptibility Testing Plate, IVD format

    There are lower than expected MICs for some gram negative species.

    FDA · DeviceRemel IncDistribution throughout the United States.Official notice →
All 13 Remel recalls →

Other drugs & medical recalls in the United States

  1. 2023-07-05
  2. US
    Drugs & medicalClass II

    Philips North America Llc recalls DigitalDiagnost C90, Model No. 712034 and 712035

    There is a software login in issue that may prevent the user from logging in.

    FDA · DevicePhilips North America LlcDistribution in US: AZ, GA, IN, IA, MN, NE, NH, OH, TX OUS distribution to…Official notice →
  3. US
    Drugs & medicalClass II

    Phadia US Inc recalls Phadia 2500EE instrument -Intended for the in vitro semi-quantitative measurement of IgG antibodies directed to gliadin in human serum or…

    Higher reported results when running EliA GliadinDP IgG Well on the instruments Phadia 2500EE compared to running EliA GliadinDP IgG Well on Phadia 250 instrument

    FDA · DevicePhadia US IncUS: CA, NJ, MIOfficial notice →
  4. US
    Drugs & medicalClass II

    RaySearch America Inc recalls Radiation therapy software, RayStation standalone software treatment planning system. Model numbers: 8B, 8B SP1, 8B SP2, 9A, 9B, 9B SP1,…

    A software bug affecting results when using deep learning (DL) segmentation followed by geometrical functions: Create wall function, Expand Contract function or ROI algebra function, the results are incorrect. If dose…

    FDA · DeviceRaySearch America IncUS: AZ, CA, GA & WAOfficial notice →
  5. US
    Drugs & medicalClass II

    Implant Direct Sybron Manufacturing LLC recalls LEGACY SMARTBASE, NE 3.0D 1MML, REF: 8730-81NE; LEGACY SMARTBASE, NE 3.0D 2MML, REF 8730-82NE; LEGACY SMARTBASE NARROW…

    Non-engaging abutments were distributed without FDA clearance; the performance characteristics have not yet been adequately established.

    FDA · DeviceImplant Direct Sybron Manufacturing LLCUS Nationwide distribution in the states of FL, ID, TX, CA.Official notice →
  6. US
    Drugs & medicalClass II

    Medtronic Neuromodulation recalls Vanta with AdaptiveStim Implantable Neurostimulator, Model 977006; spinal chord stimulation

    A cardioversion procedure may damage the electronics in the Vanta INS device, making the INS unresponsive and non-functional. As of April 19, 2023, Medtronic has received a total of two complaints concerning this issue…

    FDA · DeviceMedtronic NeuromodulationWorldwide distribution.Official notice →
  7. US
    Drugs & medicalClass II

    Hologic, Inc recalls Sertera 14 Gauge Biopsy Device-intended to obtain percutaneous core biopsy samples from soft tissue and tumors of the breast REF: SERTERA-14

    The inner needle of the Sertera device is either detaching or discharging and may cause delay in surgery

    FDA · DeviceHologic, IncUS Nationwide distribution.Official notice →
See all drugs & medical recalls →