Recall Z-1534-2021 ยท GIM Tubes, Vacuum Sample, With Anticoagulant
Greiner Bio-One North America, Inc.
VACUETTE Blood Collection tube 9NC Coagulation sodium citrate 3.2% 13x75 blue cap-white ring, sandwich tube, non-ridged - Product Usage: indicated for use in collection and transport of venous whole blood for coagulation testing.
| Date | May 6, 2021 (initiated Mar 29, 2021) |
| Status | Terminated |
| Reason | VACUETTE Blood Collection tube 9NC Coagulation sodium citrate 3.2% may show insufficient draw volume of the tubes, which could produce erroneous results for prothrombin time, activated partial thromboplastin time, and fibrinogen assays. |
| Root cause | Process control |
| Action | A Recall notification letter titled, "Urgent Product Recall" was sent to distributors on 03/29/2021 via email and to 19 end users via email on 04/01/2021. First notification mailing to all other end-users will be via UPS. First notification mailing to all other end-users will be via UPS. Assembling the mailing is in-process and the firm will notify FDA on the mailing dates and responses in their next report. Consignees were also notified by phone. The letter instructs the direct consignee to stop using the above-mentioned product (concerned item/lot) immediately and isolate defective products |
| Quantity | 1,049,700 units |
| Distribution | US Nationwide distribution in the states of KY, TX, LA, OH, AR, IL, SC, PA, FL, NC, AZ, CA, MI, NE, KS, MI, MO, NY, and NJ. |
| 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 |