CLASS II Device recall · Reported 15 Jun 2016 · FDA Enforcement Report
FX Sodium Fluoride/Potassium Oxalate tube recalled
Greiner Bio-One North America is recalling FX Sodium Fluoride/Potassium Oxalate tube, distributed nationwide in the US. The recall was initiated on 26 Apr 2016 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1923-2016
- FDA event ID
- 74002
- Recalling firm
- Greiner Bio-One North America, Monroe, NC
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 26 Apr 2016
- FDA classified
- 7 Jun 2016
- Reported
- 15 Jun 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Insulin Pumps & Glucose Monitors
Timeline
| 26 Apr 2016 | Recall initiated by company | |
| 7 Jun 2016 | Classified by FDA | +42 days |
| 15 Jun 2016 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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
Where it was distributed
Nationwide Distribution to CA, FL, IL, KY, NY, PA, VA and Puerto Rico
Nationwide CaliforniaFloridaIllinoisKentuckyNew YorkPennsylvaniaPuerto RicoVirginia
Questions about this recall
Why was it 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 lots are affected?
Lot A151137L
Where was it sold?
Nationwide Distribution to CA, FL, IL, KY, NY, PA, VA and Puerto Rico
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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|---|---|---|---|---|---|
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| Device | CLASS I | Omnipod (Eros) Pod recalled by Insulet | Insulet | Packaging Defects | Nationwide |