Z-1923-2016 Class II Terminated
FDA device recall Z-1923-2016 was initiated by Greiner Bio-One North America, Inc. on Apr 26, 2016 and is designated Class II. 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. The recall status is terminated (terminated Aug 22, 2016). Affected quantity: 250,800 pieces (209 cases).
Recall Details
- Product Type
- Devices
- Report Date
- Jun 15, 2016
- Initiation Date
- Apr 26, 2016
- Termination Date
- Aug 22, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 250,800 pieces (209 cases)
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.
Distribution Pattern
Nationwide Distribution to CA, FL, IL, KY, NY, PA, VA and Puerto Rico
Code Information
Lot A151137L