PlainRecalls
FDA Devices Moderate Class II Terminated

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

Reported: June 15, 2016 Initiated: April 26, 2016 #Z-1923-2016

Product Description

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

Reason for Recall

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.

Details

Units Affected
250,800 pieces (209 cases)
Distribution
Nationwide Distribution to CA, FL, IL, KY, NY, PA, VA and Puerto Rico
Location
Monroe, NC

Frequently Asked Questions

What product was recalled?
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. Recalled by Greiner Bio-One North America, Inc.. Units affected: 250,800 pieces (209 cases).
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on June 15, 2016. Severity: Moderate. Recall number: Z-1923-2016.