Vitek 2 Gram Positive Susceptibility Test Cards (AST-P641 REF 418590), 20 cards/kit. Product Usage: The VITEK 2 Gram Pos
FDA device recall Z-1642-2016 · posted 2016-05-11 · Terminated
Recall details
- Recalling firm
- Biomerieux Inc
- Reason for recall
- Product insert fails to identify performance limitation related to EUCAST breakpoints for Teicolplanin.
- Action taken
- Biomerieux sent an Urgent Product Correction Notice letter via email on February 24, 2016 to affected customers . The letter identified the affected product, problem and actions to be taken. Customers were asked to complete the attached Acknowledgement Form (Attachment A) and return it to Biomerieux, Inc. For questions contact your local bioMrieux representative.
- Root cause
- Labeling Change Control
- Status
- Terminated
- Product code
- LTW
- Quantity affected
- 3,594 kits
- Distribution
- Foreign distribution in the countries of Czech Republic, Hong Kong (China), Hungary, Japan, Poland, South Africa, Switzerland, and Turkey.
- Date initiated
- 2016-02-24
- Date posted
- 2016-05-11
- Date terminated
- 2018-03-08
- Location
- Hazelwood, MO
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