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.
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Discs, strips and reagents, microorganism differentiation - Product Code JTO
원인
A shipment to guadeloupe suffered a temperature excursions up to 47.8¿c, exceeding the acceptable limits. after detection of the issue, global supply chain qa asked the biom¿rieux distributor in guadeloupe to put products in quarantine in july 2017; after several reminders, the distributor informed in november 2017 that products were delivered to customers.
조치
The firm, Biomerieux, sent an "Urgent product removal notice" letter on April 23 to affected customers. The letter described the product, problem and actions to be taken. The customers were instructed to do the following:
1. Immediately acknowledge receipt (AR) of this FSCA.
2. Identify all countries and customers for which you are responsible that are impacted by this FSCA.
3. Define additional actions required (e.g. Translate customer letter, send to impacted countries/customers, etc.)
4. Distribute the customer letter to all customers that have received the products
5. Discard any impacted product remaining in local inventory
6. After all actions above are complete, please return the acknowledgement of completion (AC) for this FSCA. The due date for completion of the required actions and submitting the AC is 23-APR-2018
Subsidiaries
¿ Subsidiaries using SAP, please manage both the Acknowledgment of Receipt and the Acknowledgment of Completion of activities in SAP.
¿ Subsidiaries not using SAP, please immediately upload the Acknowledgement of Receipt in LiveLink after signing and completing sections #1 and #2. Section #3 must be signed, completed and uploaded in LiveLink before the due date.
Distributors
¿ Please immediately Acknowledge Receipt of this FSCA by completing sections #1 and #2 of the acknowledgement form and sending it by email to fieldactions@biomerieux.com or by fax to +33 4 78 87 21 79. Please remember to sign and complete all of sections #1 and #2.
¿ Sections #1 and #3 must be signed, completed, faxed or emailed before the due date.
If you have any questions, contact the Specialist, Regulatory & Quality Compliance at +33 4 78 87 56 16 or email to: charlotte.thollet@ext.biomerieux.com.
Oxidase Reagent (ref: 55635): This test is used to detect the production of the enzyme cytochrome oxidase by bacteria. This enzyme is characteristic of the genus Neisseria and most species of Pseudomonas. It enables the differentiation of Gram (-) bacilli (1, 2). || A microorganism differentiation and identification device is a device intended for medical purposes that consists of one or more components, such as differential culture media, biochemical reagents, and paper discs or paper strips impregnated with test reagents, that are usually contained in individual compartments and used to differentiate and identify selected microorganisms. The device aids in the diagnosis of disease.