Recall Z-2168-2018
BioMerieux SA · initiated March 23, 2018
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
The VITEK 2 Gram Negative Susceptibility Card is intended for use with the VITEK 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of clinically significant aerobic gram negative bacilli to antimicrobial agents. Fully automated short-term incubation cycle antimicrobial susceptibility system is a device that incorporates concentrations of antimicrobial agents into a system for the purpose of determining in vitro susceptibility of bacterial pathogens isolated from clinical specimens. Test results obtained from short-term (less than 16 hours) incubation are used to determine the antimicrobial agent of choice to treat bacterial diseases.
Codes / lots: VITEK¿ 2 AST-N233 (ref: 413117): Lot Number 6330343103
Reason for recall
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.
FDA-determined cause: Environmental control
Action taken
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.
Details
- Recall number
- Z-2168-2018
- Initiated
- March 23, 2018
- Terminated
- June 23, 2020
- Product code
- LON – System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
- Quantity
- 135 (78 boxes of various product) in total
- Distribution
- International distribution.
- Recalling firm
- BioMerieux SA, Marcy L'Etoile
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2164-2018 Class II | The VITEK 2 Gram-Positive identification card (GP) is intended for use with the VITEK 2…A shipment to Guadeloupe suffered a temperature excursions up to 47.8C, exceeding the acceptable limits.… | 03/23/2018Terminated |
| Z-2165-2018 Class II | The VITEK 2 Neisseria-Haemophilus identification card (NH) is intended for use with the…A shipment to Guadeloupe suffered a temperature excursions up to 47.8C, exceeding the acceptable limits.… | 03/23/2018Terminated |
| Z-2166-2018 Class II | The VITEK 2 Anaerobic and Corynebacteria identification card (ANC) is intended for use…A shipment to Guadeloupe suffered a temperature excursions up to 47.8C, exceeding the acceptable limits.… | 03/23/2018Terminated |
| Z-2167-2018 Class II | The VITEK 2 Gram Positive Susceptibility Card is intended for use with the VITEK 2…A shipment to Guadeloupe suffered a temperature excursions up to 47.8C, exceeding the acceptable limits.… | 03/23/2018Terminated |
| Z-2169-2018 Class II | VIDAS TOXO IgG Avidity is an automated qualitative test for use on the VIDAS family…A shipment to Guadeloupe suffered a temperature excursions up to 47.8C, exceeding the acceptable limits.… | 03/23/2018Terminated |
| Z-2170-2018 Class II | The PREVI Color Gram dyes are used with the PREVI Color Gram instrument to stain…A shipment to Guadeloupe suffered a temperature excursions up to 47.8C, exceeding the acceptable limits.… | 03/23/2018Terminated |
| Z-2171-2018 Class II | Color Gram 2 (COLOR GRAM 2 - F), these stains are used to stain bacterial and fungal…A shipment to Guadeloupe suffered a temperature excursions up to 47.8C, exceeding the acceptable limits.… | 03/23/2018Terminated |
| Z-2172-2018 Class II | Oxidase Reagent (ref: 55635): This test is used to detect the production of the enzyme…A shipment to Guadeloupe suffered a temperature excursions up to 47.8C, exceeding the acceptable limits.… | 03/23/2018Terminated |