VACUETTE TUBE 4 ml FX Sodium Fluoride/Potassium Oxalate… recallZ-0733-2024 · Greiner Bio-One North America, Inc. · initiated Dec 12, 2023
Open, Classified
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
Tubes have missing additive/anticoagulant resulting in clotting in most cases. A completely clotted sample would lead to no results being reported, which could lead to a delay in treatment or diagnosis. An erroneous glucose or lactose result from a partially clotted sample could lead to inappropriate treatment.
FDA root cause category: Software design
What the company is doing
Distributors were emailed the notification letter dated 12/11/2023 on 12/12/2023 and the other consignees were sent the letter on 12/13-14/2023 via email or USPS. The distributor letter explained the issue, identified the product, the potential health hazard, informed the consignee they should not use the tubes, and requests use of the product immediately be stopped and the product be isolated in their facility. The consignee should assess the risks and consequences of the use of the defective product in accordance with their procedures and take appropriate action. The enclosed Product Disposition Site Confirmation form is to be returned via email or FAX to confirm the consignee has discarded/destroyed all recalled product in their possession. Distributors were informed that their customers should notified and the letter requests the distributor to provide the recalling firm with a list of their customers who received the product along with the date and quantity that was shipped to the customer. The letter going to other customers provided the same information as the distributor letter except no subrecall information was mentioned within the letter, but the response form requests any facility or location to whom the tubes were forwarded should be advised of the recall and the names of those facilities/locations were to be provided to the recalling firm.
Recall details
- Recall number
- Z-0733-2024
- Status
- Open, Classified
- Initiated by the company
- Dec 12, 2023
- Posted by the FDA
- Jan 16, 2024
- Recalling firm
- Greiner Bio-One North America, Inc.
- Quantity
- 495,600 tubes
- Product code
- JKA
- FDA submissions
- K971239
- Distribution
- US Nationwide distribution in the states of CT, FL, IA, IL, MO, NC, NY, PA, TN, and VA.
Product description
VACUETTE TUBE 4 ml FX Sodium Fluoride/Potassium Oxalate, Item #454297, 13x75 grey cap-black ring, non-ridged.
Code information (models, lots, serial numbers)
Lot #A221135N, Exp. date 03/02/2024, UDI-DI Case label 39120017575130, UDI Rack label 29120017575133.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Vacuette 454297Greiner Bio-One GmbH · Tubes, vials, systems, serum separators, blood collection1 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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