ETEST Fosfomycin FM1024 Blister packaging, Product Name:… recallZ-1528-2017 · BioMerieux SA · initiated Dec 15, 2016

Why it was recalled

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

FDA root cause category: Storage

What the company is doing

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.

Recall details

Recall number

Z-1528-2017

Recall class

Class II

Status

Terminated

Initiated by the company

Dec 15, 2016

Posted by the FDA

Mar 21, 2017

Recalling firm

BioMerieux SA

Quantity

unknown

Product code

JWY

FDA submissions

K981136

Distribution

Worldwide Distribution - U.S.( Nationwide); Foreign: Utd.Arab Emir., Argentina, Austria, Australia, Brazil, Canada, Switzerland, Chile, Colombia, Czech Republic, Germany, Algeria, Spain, France, United Kingdom, Greece, Hong Kong, India, Italy, Japan, South Korea, Mexico, Netherlands, Poland, Portugal, Russian, Fed. Sweden, Singapore, Thailand, Turkey, South Africa, Indonesia, Peru, Saudi Arabia, Gabon, Kazakhstan, Philippines, Ivory Coast, Venezuela, Kenya, Serbia, Tunisia, Macedonia, Lebanon, Romania, Benin, Bosnia-Herz., Oman, Uruguay, Lithuania, Burkina Faso, Slovenia, Qatar, Kuwait, Costa Rica, Paraguay, Dominican Republic, Croatia, Panama, Congo, Dem. Rep. Congo, Honduras, Estonia, Latvia, Cambodia, Bulgaria, Vietnam, Dutch Antilles, Nicaragua, Israel, Georgia, Palestine, Egypt, Pakistan (includ.Afghanistan), Malta, Jordan Bahrain, El Salvador, Nigeria, Dutch Antilles, Iran, Belarus, Zimbabwe, Morocco, Mauretania, Anguilla, Philippines, Malaysia, Turkmenistan, Guam, Brunei, Bolivia, Guatemala, Ecuador, Belarus, Mongolia

Product description

ETEST Fosfomycin FM1024 Blister packaging, Product Name: ETEST Fosfomycin FM 0.064-1024. ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria such as Enterobacteriaceae, Pseudomonas, Staphylococcus and Enterococcus species and fastidious bacteria, such as anaerobes, N. gonorrhoeae, S. pneumoniae, Streptococcus and Haemophilus species. The system comprises a predefined antibiotic gradient which is used to determine the Minimum Inhibitory Concentration (MIC), in g/mL, of different antimicrobial agents against microorganisms as tested on agar media using overnight incubation. Current Antimicrobial Susceptibility Testing (AST) methods are based either on quantitative dilution techniques or qualitative diffusion procedures. Dilution methods are based on two-fold serial dilutions of antibiotics in broth or agar media. These methods generate the MIC value i.e. Minimum Inhibitory Concentration of a given antibiotic in g/mL that will inhibit the growth of a particular bacterium under defined experimental conditions

Other devices under the same FDA submission

1 device cleared under K981136 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

• ETEST® Fosfomycin (FM)

  Biomerieux SA · Manual Antimicrobial Susceptibility Test Systems
  2 reports

Other products in the same recall event

The FDA groups related products into one recall event (event 76201).

• Z-1521-2017 · Terminated
  ETEST Ceftazidime TZ256 Foam packaging, Product Name: ETEST Ceftazidime TZ 0.016-256. ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-neg…
• Z-1522-2017 · Terminated
  ETEST Cephalotin CE 256 Foam packaging, Product Name: ETEST Cephalothin CE 0.016-256. ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-neg…
• Z-1523-2017 · Terminated
  ETEST Ceftriaxone TXL32 SPB, Product Name: ETEST Ceftriaxone TX 0.002-32(low). ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative a…
• Z-1525-2017 · Terminated
  ETEST Vancomycin VA 256 FOAM packaging, Product Name: ETEST Vancomycin VA 0.016-256. ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-nega…
• Z-1527-2017 · Terminated
  ETEST Benzyl Penicillin PG256 FOAM packaging, Product Name: Etest Benzylpenicillin PG 0.016-256 (high). ETEST is a quantitative technique for determining the antimicrobial suscepti…
• Z-1529-2017 · Terminated
  ETEST Imipenem IP32 Foam packaging, Product Name: ETEST Imipenem IP 0.002-32. ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative an…
• Z-1530-2017 · Terminated
  ETEST Gentamicin GM256 FOAM packaging, Product Name: ETEST Gentamicin GM 0.016-256(low). ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-…
• Z-1531-2017 · Terminated
  ETEST Tobramycin TM256 FOAM packaging, Product Name: ETEST Tobramycin TM 0.016-256(low). ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram-…
• Z-1532-2017 · Terminated
  ETEST Ceftriaxone TXL32 FOAM packaging, Product Name: ETEST Ceftriaxone TX 0.002-32(low). ETEST is a quantitative technique for determining the antimicrobial susceptibility of Gram…