VACUETTE¿ Blood Collection tube 9NC Coagulation sodium citrate 3 — Class II medical device recall Z-1534-2021

Terminated recall by Greiner Bio-One North America, Inc., reported 2021-05-12, distributed nationwide. VACUETTE¿ Blood Collection tube 9NC Coagulation sodium citrate 3.2% may show insufficient draw volume of the t

Recall number	`Z-1534-2021`
Product type	Medical device
Classification	Class II
Status	Terminated
Voluntary or mandated	Voluntary
Recalling firm	Greiner Bio-One North America, Inc., Monroe, NC, United States
Recall initiated	2021-03-29
Classified	2021-05-06
Reported by FDA	2021-05-12
Terminated	2023-10-10
Distributed	Nationwide (US)
Quantity	1,049,700 units
UPC / GTIN / UDI-DI	`29120017574488`, `29120017574532`, `29120017574600`, `39120017574485`, `39120017574539`, `39120017574607`
Lot numbers	`A210233V`, `A21023B5`, `A21023XW`, `A210338Q`
Model numbers	`454322`, `454332`, `454334`
Expiration dates	`2022-02-01`, `2022-02-06`, `2022-02-13`, `2022-03-01`

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 for recall

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1534-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.