Recall Z-1923-2016 ยท JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Greiner Bio-One North America, Inc.
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
| Date | Apr 26, 2016 |
| Status | Terminated |
| 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. |
| 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 | 250,800 pieces (209 cases) |
| Distribution | Nationwide Distribution to CA, FL, IL, KY, NY, PA, VA and Puerto Rico |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K971239 | GREINER VACUETTE BLOOD COLLECTION TUBE Greiner America, Inc., May 12, 1997 |