Date Initiated by Firm | November 09, 2022 |
Date Posted | January 04, 2023 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-0861-2023 |
Recall Event ID |
91148 |
510(K)Number | K152075 |
Product Classification |
System, test, automated, antimicrobial susceptibility, short incubation - Product Code LON
|
Product | VITEK 2 REAGENT AST-XN15 TEST KIT 20 CARDS, CATALOG 423829 |
Code Information |
UDI/DI 03573026620288, Batch Numbers: 8312243203
|
Recalling Firm/ Manufacturer |
Biomerieux Inc 595 Anglum Rd Hazelwood MO 63042-2320
|
For Additional Information Contact | Clinical Customer Support 800-682-2666 |
Manufacturer Reason for Recall | As the temperature and time out of range was exceeded, product performances cannot be guaranteed |
FDA Determined Cause 2 | Storage |
Action | Biomerieux sent a FIELD SAFETY CORRECTIVE ACTION notice to the US subsidiary on 11/09/2022 by email. The notice requested the subsidiary identify their customers and issue an URGENT FIELD SAFETY NOTICE which explains the problem and request the following actions:
"1. Confirm this letter has been distributed to and reviewed by all appropriate personnel within your organization.
2. Check your inventory for any of the impacted products (reference Table 1) associated with local shipments.
3. Stop using and scrap any remaining impacted products in your inventory.
a. Request product replacement or credit for the destroyed product.
b. Document the quantity destroyed in the Product Information section of the attached Acknowledgement
Form.
4. Please store this letter with your bioMrieux documentation.
5. Complete the attached Acknowledgement Form and return it to your local bioMrieux representative as soon
as possible."
The customer notices were sent by FedEx Overnight Letter on 18 NOV 2022. |
Quantity in Commerce | 58 units |
Distribution | US Nationwide 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
|
510(K) Database | 510(K)s with Product Code = LON
|