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.

Recall number

Z-1534-2021

Recalling firm

Greiner Bio-One North America, Inc.

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.

Status

Terminated

Initiated

2021-03-29

Posted

2021-05-06

Terminated

2023-10-10

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 in the consignee facility; assess risks and consequences for the use of this defective product in accordance with the consignee's procedures and take appropriate action; complete the attached Product Disposition Site Confirmation form and fax to Greiner Bio-One North America, Inc. at 800.726.0052 or email to patech@gbo.com. This form is to confirm that the consignees have discarded/destroyed all products from these items/lots. The firm will replace the product after the completed form is sent to Greiner. The notice sent to the distributors instructs them to stop distributing the above-mentioned product (concerned items/lots) immediately and isolate defective products in their facility. Complete the attached Product Disposition form and fax it to Greiner at 800.726.0052 or email to patech@gbo.com. The firm will contact the distributor for the return or destruction of the product after receiving the attached Product Disposition Site Confirmation form. The firm will use this information to send you replacement stock or issue a credit. The firm informs the distributor that it is a legal obligation to notify customers. Therefore, the firm is requesting that the distributor please provide them with a list of their customers that have received the item with this specific lot number. Include: Facility, Address, Key contact, Phone number, Fax, and Date shipped. Please provide this as

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.

Lot, serial or model codes

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

510(k) numbers

["K971221"]

PMA numbers

not on file

Product code

GIM

Firm FEI

3001451379

Firm city

Monroe

Firm state

NC

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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