FDAClass IIJune 15, 2016

4 ml FX Sodium Fluoride/Potassium Oxalate tube recall

4 ml FX Sodium Fluoride/Potassium Oxalate tube, Ref 454297 VACUETTE Glycolytic Inhibitor Tubes contain an antiglycolytic agent, sodium fluoride, and…

Why was 4 ml FX Sodium Fluoride/Potassium Oxalate tube 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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot A151137L

Product
4 ml FX Sodium Fluoride/Potassium Oxalate tube, Ref 454297 VACUETTE Glycolytic Inhibitor Tubes contain an antiglycolytic agent, sodium fluoride, and…
Recalling firm
Greiner Bio-One North America, Inc.
Quantity
250,800 pieces (209 cases)
Distribution
Nationwide Distribution to CA, FL, IL, KY, NY, PA, VA and Puerto Rico
Recall date
June 15, 2016
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls