Z-1923-2016Class II

4 ml FX Sodium Fluoride/Potassium Oxalate tube, Ref 454297 VACUETTE Glycolytic Inhibitor Tubes contain an...

Name: Z-1923-2016 4 ml FX Sodium Fluoride/Potassium Oxalate tube, Ref 454297 VACUETTE Glycolytic Inhibitor Tubes contain an...
Creator: Greiner Bio-One North America, Inc.
Published: 2016-04-26
License: https://open.fda.gov/license/

Greiner Bio-One North America, Inc. / initiated 2016-04-26 / Terminated / root cause: manufacturing process

FDA source

Greiner Bio-One North America, Inc. began a recall of 4 ml FX Sodium Fluoride/Potassium Oxalate tube, Ref 454297 VACUETTE Glycolytic Inhibitor Tubes contain an antiglycolytic agent, sodium fluoride, and an... on 2016-04-26. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1923-2016
Classification: Class II
Status: Terminated
Initiated: 2016-04-26
Posted: 2016-06-07
Terminated: 2016-08-22
Recalling firm: Greiner Bio-One North America, Inc.
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
Product code: JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Greiner Bio-One North America, Inc. sent an Urgent Product Recall letter dated April 26, 2016, to all affected consignees. The letter requested that they stop distribution of the product and to provide Greiner with a list of their sub-accounts. The letter included a Product Disposition/Site Confirmation form which is to be returned to Greiner Bio-one. Consignees with questions were instructed to call 800-515-8112. For questions regarding this recall call 704-261-7823.
Quantity in commerce: 250,800 pieces (209 cases)
Distribution: Nationwide Distribution to CA, FL, IL, KY, NY, PA, VA and Puerto Rico
Product codes and lots: Lot A151137L

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1923-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1923-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-15	2016-06-07

Product code JKA

K971239Class IIGreiner Vacuette Blood Collection TubeGreiner America, Inc. / cleared 1997-05-12

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)