U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Alere is initiating a voluntary recall on the listed lots of multi-drug 9 panel integrated cup manufactured by alere for sole use by calloway labs due to a mistake that occurred while processing the order, these products were incorrectly
labeled as clia waived, when in fact the devices are classified as moderately complex. therefore these devices are misbranded.
조치
Alere San Diego sent an "Urgent Medical Device Recall" letter dated June 9, 2011 to all affected customers.
The letter included: products affected, reason for recall and instructed them to return all affected product. An acknowledgement form was also included for the customer to return to Alere.
For questions contact Technical Services at 888.246.7483, option 2 or by e-mail at InnovaconComplaints@alere.com.
(USA) Nationwide Distribution including the states of MO and MA.
제품 설명
Calloway LabsMulti-Drug 9 Panel Assay || A rapid, one step screening test for the simultaneous for the qualitative detection of multiple drugs and drug metabolites in human urine.
“We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.