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Recall Observatory FDA recall evidence

Device product

4 ml FX Sodium Fluoride/Potassium Oxalate tube, Ref 454297 VACUETTE Glycolytic Inhibitor Tubes contain an antiglycolytic agent, sodium fluoride, and an anticoagulant, potassium oxalate. The product is suitable for the analysis of blood glucose and lactate

Z-1923-2016

April 26, 2016

Class II

Product summary

Firm
Greiner Bio-One North America, Inc.
Event
Event 74002
Status
Terminated
Classification
Class II
Quantity
250,800 pieces (209 cases)
Official record key
device-enforcement:Z-1923-2016

Official wording

Reason: The 4 ml FX Sodium Fluoride/Potassium Oxalate tube may have no or low additive (sodium fluoride and potassium oxalate), which can effect analytical results for glucose and lactate.

Code information: Lot A151137L

Distribution pattern: Nationwide Distribution to CA, FL, IL, KY, NY, PA, VA and Puerto Rico

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The 4 ml FX Sodium Fluoride/Potassium Oxalate tube may have no or low additive (sodium fluoride and potassium oxalate), which can effect analytical results for glucose and lactate.