VACUETTE Blood Collection tube 9NC Coagulation sodium… recallZ-1534-2021 · Greiner Bio-One North America, Inc. · initiated Mar 29, 2021
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Greiner Bio-One North America, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Process control
What the company is doing
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
Recall details
- Recall number
- Z-1534-2021
- Status
- Terminated
- Initiated by the company
- Mar 29, 2021
- Posted by the FDA
- May 6, 2021
- Recalling firm
- Greiner Bio-One North America, Inc.
- Quantity
- 1,049,700 units
- Product code
- GIM
- FDA submissions
- K971221
- 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 description
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.
Code information (models, lots, serial numbers)
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
Devices named in this recall
3 devices in the FDA device registry whose identifier appears in the recall's code information.
- Vacuette 454322Greiner Bio-One GmbH · Tubes, vacuum sample, with anticoagulant3 recalls0 reports
- Vacuette 454334Greiner Bio-One GmbH · Tubes, vacuum sample, with anticoagulant1 recall0 reports
- Vacuette 454332Greiner Bio-One GmbH · Tubes, vacuum sample, with anticoagulant1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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