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U.S. Department of Health and Human Services

Class 2 Device Recall Biomerieux

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  Class 2 Device Recall Biomerieux see related information
Date Initiated by Firm March 23, 2018
Create Date June 12, 2018
Recall Status1 Terminated 3 on June 23, 2020
Recall Number Z-2170-2018
Recall Event ID 80111
Product Classification Slide stainer, automated - Product Code KPA
Product The PREVI¿ Color Gram dyes are used with the PREVI¿ Color Gram instrument to stain bacterial and fungal microorganisms for direct examination, according to Gram s method.

The PREVI¿ Color Gram instrument sprays the PREVI¿ Color Gram reagents onto microscope slides which have been smeared with specimens to be examined. The staining procedure is rapid and precise. Each reagent has a specific position (A, B, C, D, E) on the PREVI¿ Color Gram platform that is also indicated on the reagent label.

An automated slide stainer is a device used to stain histology, cytology, and hematology slides for diagnosis.
Code Information Reagents for use with the PREVI¿ Color Gram:  IODINE-B (ref: 29523) Lot number: G59407 Exp. 15-Aug-18 CRYSTAL VIOLET-C (ref: 29524) Lot number: G52306 Exp.19-Jul-18 FUCHSIN-A (ref: 29522): Lot Number Lot number: F89544 Exp. 13-Apr-18
Recalling Firm/
Manufacturer		 BioMerieux SA
Chemin De L'Orme
Marcy L'Etoile France
Manufacturer Reason
for Recall		 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.
FDA Determined
Cause 2		 Environmental control
Action 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.
Quantity in Commerce FUCHSIN-A (ref: 29522) 15 eaches; IODINE-B (ref: 29523) 10 eaches ; CRYSTAL VIOLET-C (ref: 29524) 10 eaches
Distribution International distribution.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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