FDA Device recall Z-1534-2021
VACUETTE¿ Blood Collection tube 9NC Coagulation sodium citrate 3.2% 13x75 blue cap-white ring, sandwich tube, non-ridged - Product Usage: i…
- FDA Device
- Class II
- terminated
- Published 2021-05-12
On 2021-05-12 the FDA classified a Class II recall of VACUETTE¿ Blood Collection tube 9NC Coagulation sodium citrate 3.2% 13x75 blue cap-white ring, sandwich tube, non-ridged - Product Usage: i… by Greiner Bio One North America, citing 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, act….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1534-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-03-29 |
| Published | 2021-05-12 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Greiner Bio One North America |
| Distribution | US |
Product
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.
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.
Identifiers
| code_info | Item Number: 454322; Lot # A21023B5; UDI: (Case) 39120017574485 and (Rack) 29120017574488; Expiration Date: 02/06/2022…Item Number: 454322; Lot # A21023B5; UDI: (Case) 39120017574485 and (Rack) 29120017574488; Expiration Date: 02/06/2022 Item Number: 454332; Lot # A210338Q; UDI: (Case) 39120017574607 and (Rack) 29120017574600; Expiration Date: 03/01/2022 Item Number: 454334; Lot # A210233V; UDI: (Case) 39120017574539 and (Rack) 29120017574532; Expiration Date: 02/01/2022 Item Number: 454334; Lot # A21023XW; UDI: (Case) 39120017574539 and (Rack) 29120017574532; Expiration Date: 02/13/2022 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1534-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.