ETEST Vancomycin VA 256 FOAM packaging, Product Name: ETEST Vancomycin VA 0.016-256. ETEST is a quantitative technique f

FDA device recall Z-1525-2017 · posted 2017-03-21 · Terminated

Recall details

Recalling firm

BioMerieux SA

Reason for recall

Product Stability issues: The current shelf-life claims of the ETEST products are not supported by internal testing.

Action taken

biomerieux sent an Urgent Field Safety Notice dated December 15, 2016, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were instructed to identify the affected lots and immediately order the replacement products. Laboratories should continue to follow their current QC procedures. When replacement product is received, consignees should discontinue using any discard affected product. Consignees should distribute this information to all appropriate personnel in their laboratory, retain a copy in their files, and forward the information to all parties that may use this product, including others to whom they may have transferred our product. Consignees should contact their bioMerieux representative for product compensation. Consignees should also complete and return the Acknowledgment Form in Attachment A by Fax to confirm receipt of the notice. Consignees with questions should contact their local bioMerieux Clinical Customer Service representative. For questions regarding this recall call 314-731-8516.

Root cause

Storage

Status

Terminated

Product code

JWY

Quantity affected

unknown

Distribution

Worldwide Distribution - U.S.( Nationwide); Foreign: Utd.Arab Emir., Argentina, Austria, Australia, Brazil, Canada, Switzerland, Chile, Colombia, Czech Republic, Germany, Algeria, Spain, France, Unite

Date initiated

2016-12-15

Date posted

2017-03-21

Date terminated

2020-08-18

Location

Marcy L'Etoile, France

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