Z-1534-2021Class II

VACUETTE Blood Collection tube 9NC Coagulation sodium citrate 3.2% 13x75 blue cap-white ring, sandwich tube...

Name: Z-1534-2021 VACUETTE Blood Collection tube 9NC Coagulation sodium citrate 3.2% 13x75 blue cap-white ring, sandwich tube...
Creator: Greiner Bio-One North America, Inc.
Published: 2021-03-29
License: https://open.fda.gov/license/

Greiner Bio-One North America, Inc. / initiated 2021-03-29 / Terminated / root cause: manufacturing process

FDA source

Greiner Bio-One North America, Inc. began a recall of 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... on 2021-03-29. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1534-2021
Classification: Class II
Status: Terminated
Initiated: 2021-03-29
Posted: 2021-05-06
Terminated: 2023-10-10
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.
Product code: GIM Tubes, Vacuum Sample, With Anticoagulant
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.
Root cause tag: manufacturing process
FDA 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 [email protected]. 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 [email protected]. 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 in commerce: 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1534-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1534-2021	Class II	Terminated	Voluntary: Firm initiated	2021-05-12	2021-05-06

Product code GIM

K971221Class IIGreiner Vacuette Blood Collection TubeGreiner America, Inc. / cleared 1997-05-02

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)