Recall Z-1923-2016— Greiner Bio-One North America, Inc.

Name: FDA recall Z-1923-2016
Creator: U.S. Food and Drug Administration
Published: 2016-04-26

Class II · Terminated

Class II FDA medical device recall by Greiner Bio-One North America, Inc., initiated 2016-04-26, terminated 2016-08-22. It names one FDA 510(k) clearance: K971239. 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. 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..

Recalling firm: Greiner Bio-One North America, Inc.
Classification: Class II
Status: Terminated
Initiated: 2016-04-26
Terminated: 2016-08-22
Firm location: Monroe, NC, United States

510(k) clearances named in this recall

1 on FDA's record

K971239 — GREINER VACUETTE BLOOD COLLECTION TUBEGreiner America, Inc.·cleared 1997-05-12

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.