Recall Z-1714-2020 ยท GIM Tubes, Vacuum Sample, With Anticoagulant
Greiner Bio-One North America, Inc.
VACUETTE Tube 2ml 9NC Coagulation Sodium Citrate 3.2%. Item no. 454322. Lot no. B1908355.
| Date | Mar 12, 2020 |
| Status | Terminated |
| Reason | Concerned lot of VACETTE 2mL 9NC Coagulation Tubes were shown to have inconsistent amounts of the 2.3% sodium citrate. |
| Root cause | Process change control |
| Action | Greiner Bio-One North America Inc., notified customers on 03/12/2020 via "Urgent Product Recall" letter. The recall letter identified the affected products and requested the users to stop using the product and complete the product disposition site confirmation form. Consignees were asked to discard/destroy the affected products. If you have additional questions, please call our Technical Service at 800-815-8112. |
| Quantity | 1,000,800 units. |
| Distribution | US nationwide distribution in the states of: NJ, IN, TN, MI, NC, WA, KS, CA, LA, IL, MD, NY, OH, TX, GA, KY, PA, CO, MA, PR, FL, AR, OK and NE. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K971221 | GREINER VACUETTE BLOOD COLLECTION TUBE Greiner America, Inc., May 2, 1997 |