BioMerieux SA: 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.

Recall number

Z-2170-2018

Recalling firm

BioMerieux SA

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.

Status

Terminated

Initiated

2018-03-23

Posted

not on file

Terminated

2020-06-23

Reason

A shipment to Guadeloupe suffered a temperature excursions up to 47.8C, exceeding the acceptable limits. After detection of the issue, Global Supply Chain QA asked the bioMrieux 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.

Root cause

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

FUCHSIN-A (ref: 29522) 15 eaches; IODINE-B (ref: 29523) 10 eaches ; CRYSTAL VIOLET-C (ref: 29524) 10 eaches

Distribution

International distribution.

Lot, serial or model codes

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

510(k) numbers

not on file

PMA numbers

not on file

Product code

KPA

Firm FEI

1000611339

Firm city

Marcy L'Etoile

Firm state

not on file

Firm country

France

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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