Drugs & medicalClass II

IMMUNDIAGNOSTIK, Inc recalls Immundiagnostik IDK Lactoferrin ELISA- In vitro enzyme immunoassay intended for the determination of lactoferrin in stool. P/N: K6870…

Marketed without a 510k

Read the official notice →
Date
2023-05-24
Country
United States
Brand
IMMUNDIAGNOSTIK, Inc
Product
Immundiagnostik IDK Lactoferrin ELISA- In vitro enzyme immunoassay intended for the determination of lactoferrin in stool. P/N: K6870…
Classification
Class II
Units
US Nationwide Distribution: CA, IL, NC, NH, OR
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 Details may be shortened or out of date; the official notice is the authoritative source.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.

Other drugs & medical recalls in the United States

  1. 2023-05-24
  2. US
    Drugs & medicalClass II

    Beckman Coulter Inc. recalls Beckman Coulter Bicarbonate, REF: OSR6137, 4x25 mL

    There is a potential for a decrease in calibration ODs for Bicarbonate reagent which could result in calibration failures and/or quality control failures.

    FDA · DeviceBeckman Coulter Inc.Worldwide Distribution: US (nationwide): AK, AL, AR, AZ, CA, CO, CT, DC, DE,…Official notice →
  3. US
    Drugs & medicalClass II

    Access Vascular, Inc recalls HydroPICC 4Fr Single Lumen Catheter, Maximal Barrier Kit, Model Number 80001004

    The catheter packaged with specific lots of the HydroPICC Kits and HydroMID Kits have a shorter expiration date than what is listed on the outer kit package.

    FDA · DeviceAccess Vascular, IncUS distribution to States of: FL, TN, TX.Official notice →
  4. US
    Drugs & medicalClass II

    Hiossen Inc. recalls ET III Nano-HA fixture System ET NH Dental Implant Model # ET3R5010B -Intended for Dental Implant Catalog #: AET3R5010B

    Mis-labeled length of the dental implant on the Recall Implant's package. Dental implant size D5.0 x L8.5mm, labeled as D5.0 x L10mm

    FDA · DeviceHiossen Inc.US Nationwide DistributionOfficial notice →
  5. US
    Drugs & medicalClass II

    Surgical Innovations Ltd recalls YelloPort Elite, REF: EO0509505, 5x95 Optical Trocar, Rx Only, SterileR

    Optical Trocars sterility assurance can not be guaranteed

    FDA · DeviceSurgical Innovations LtdUS: MA OUS: NoneOfficial notice →
  6. US
    Drugs & medicalClass II

    Fisher Wallace Laboratories Inc. recalls Fisher Wallace Stimulator Models FW-100 and FW-200

    If the batteries are installed incorrectly, the product may overheat, possibly leading to pain, discomfort, irritation, or even burns during use of the device.

    FDA · DeviceFisher Wallace Laboratories Inc.US Nationwide. Global Distribution.Official notice →
  7. US
    Drugs & medicalClass II

    Beckman Coulter, Inc. recalls DxU 840m Iris Urine Microscopy Analyzer, Catalog Number C76947, in-vitro diagnostic device, urine analysis

    Beckman Coulter has become aware of an intermittent issue in which the optional flag "Previous Sample Had Sperm" was enabled but not displayed so that a carryover event could have been investigated.

    FDA · DeviceBeckman Coulter, Inc.Worldwide DistributionOfficial notice →
See all drugs & medical recalls →