| 2025-08-19 |
Class II
|
Ongoing |
Z-0571-2026 |
Brand Name: Vacuette Product Name: 8 ml CAT Serum Separator Clot Activator Model/Catalog Number: 455071P Product Desc… |
— |
Some of the Vacuette¿ CAT Serum Separator Clot Activator tubes were manufactured without gel separator, which could yield erroneous assay results and require th… |
| 2025-08-08 |
Class II
|
Ongoing |
Z-0408-2026 |
Greiner BIO-ONE VACUETTE 2 ml 9NC Coagulation sodium citrate 3.2%, REF: 454322 |
— |
Blood collection tubes were manufactured with the label applied too high on the tube, which shifted the printed fill level mark upward, which could result in u… |
| 2024-05-14 |
Class II
|
Ongoing |
Z-2375-2024 |
VACUETTE¿ TUBE 8 ml CAT Serum Separator Clot Activator 16x100 red cap-yellow ring, non-ridged |
— |
The firm received reports that some blood collection tubes have experienced issues with clotting and poor separation due to missing additive. The failure of the… |
| 2023-12-12 |
Class II
|
Ongoing |
Z-0733-2024 |
VACUETTE TUBE 4 ml FX Sodium Fluoride/Potassium Oxalate, Item #454297, 13x75 grey cap-black ring, non-ridged. |
— |
Tubes have missing additive/anticoagulant resulting in clotting in most cases. A completely clotted sample would lead to no results being reported, which could … |
| 2023-03-31 |
Class II
|
Completed |
Z-1583-2023 |
greiner bio-one VACUETTE TUBE 6 ml K3E K3EDTA, 13x100 pink cap-black ring, non-ridged, 24 racks of 50 pcs., 1200 pcs in … |
— |
Some of the tubes may be incorrectly labeled. |
| 2021-12-09 |
Class II
|
Terminated |
Z-0502-2022 |
greiner bio-one VACUETTE TUBE, 5 ml LH Lithium Heparin Sep, 13x100 green cap-yellow ring, non-ridged, 24 racks of 50 pcs… |
— |
Some of the blood collection tubes show clotting due to variation of Lithium Heparin. |
| 2021-08-20 |
Class II
|
Terminated |
Z-2507-2021 |
Greiner Bio-One VACUETTE¿ TUBE 2 ml 9NC Coagulation sodium citrate 3.2% 13x75 blue cap-white ring, sandwich tube, non-ri… |
— |
Complaint of tubes clotting due to variation of anticoagulant and/or tubes have low vacuum. |
| 2021-08-13 |
Class II
|
Terminated |
Z-2485-2021 |
VACUETTE TUBE 6 ml K2E K2EDTA 13x100 pink cap-pink ring, non-ridged |
— |
Blood collection tubes may experience a clotting issue. |
| 2021-03-29 |
Class II
|
Terminated |
Z-1534-2021 |
VACUETTE¿ Blood Collection tube 9NC Coagulation sodium citrate 3.2% 13x75 blue cap-white ring, sandwich tube, non-ridged… |
— |
VACUETTE¿ Blood Collection tube 9NC Coagulation sodium citrate 3.2% may show insufficient draw volume of the tubes, which could produce erroneous results for pr… |
| 2020-08-28 |
Class II
|
Terminated |
Z-3027-2020 |
VACUETTE TUBE 5 mL CAT Serum Separator Clot Activator, Item Number: 456018P - Product Usage: are used to collect, transp… |
— |
Blood collection tubes experienced an issue with separation and clotting |
| 2020-03-12 |
Class II
|
Terminated |
Z-1714-2020 |
VACUETTE Tube 2ml 9NC Coagulation Sodium Citrate 3.2%. Item no. 454322. Lot no. B1908355. |
— |
Concerned lot of VACETTE 2mL 9NC Coagulation Tubes were shown to have inconsistent amounts of the 2.3% sodium citrate. |