The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2770-2017·Announced 2017-08-02

Biomerieux Recalls VITEK 2 Gram Negative Test Kits Due to Errors

Biomerieux Inc is recalling VITEK 2 Gram Negative test kits containing colistin because they produced high rates of major errors in susceptibility testing.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk of harm (misdiagnosis of antibiotic resistance) where specific injury reports are not detailed in the source text, fitting the 'High' severity criteria for risk-of-harm products.

Plain-English summary

Biomerieux Inc is recalling 1,520,000 VITEK 2 Gram Negative test kits containing colistin (cs01n). The recall was initiated after an investigation demonstrated a high rate of very major errors, where resistant bacterial isolates were incorrectly identified as susceptible. These errors were observed when comparing the test kits to agar dilution and broth-microdilution methods, which are the reference and recommended methods for colistin testing.

The affected products were distributed domestically in North Carolina and internationally to numerous countries, including Argentina, Austria, Brazil, Canada, and the United Kingdom. The specific reference numbers for the affected kits are listed in the agency's recall documentation.

Healthcare facilities and laboratories should stop using the affected VITEK 2 Gram Negative test kits immediately. Users should contact Biomerieux Inc for instructions on how to return the products for a refund or replacement.

The recalled product

Product
VITEK 2 Gram Negative test kits containing colistin (cs01n)
Manufacturer
Biomerieux Inc
Category
Medical Device — Laboratory Test Kit
Hazard
Affected units
1,520,000

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • REF # (Description): 418114 (AST-GN94)
  • 22258 (AST-N102)
  • 412605 (AST-N194)
  • 412921 (AST-N199)
  • 412862 (AST-N201)
  • 412863 (AST-N202)
  • 412924 (AST-N205)
  • 412918 (AST-N210)
  • 413061 (AST-N212)
  • 413083 (AST-N222)
  • 413112 (AST-N225)
  • 413171 (AST-N236)
  • 413172 (AST-N237)
  • 413204 (AST-N239)
  • 413205 (AST-N240)
  • 413391 (AST-N242)
  • 413394 (AST-N245)
  • 413397 (AST-N248)
  • 413572 (AST-N249)
  • 413722 (AST-N253)

Distribution

Distributed in 1 state:

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