Z-0733-2024Class II

VACUETTE TUBE 4 ml FX Sodium Fluoride/Potassium Oxalate, Item #454297, 13x75 grey cap-black ring, non-ridged

Name: Z-0733-2024 VACUETTE TUBE 4 ml FX Sodium Fluoride/Potassium Oxalate, Item #454297, 13x75 grey cap-black ring, non-ridged
Creator: Greiner Bio-One North America, Inc.
Published: 2023-12-12
License: https://open.fda.gov/license/

Greiner Bio-One North America, Inc. / initiated 2023-12-12 / Open, Classified / root cause: software

FDA source

Greiner Bio-One North America, Inc. began a recall of VACUETTE TUBE 4 ml FX Sodium Fluoride/Potassium Oxalate, Item #454297, 13x75 grey cap-black ring, non-ridged on 2023-12-12. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-0733-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-12-12
Posted: 2024-01-16
Recalling firm: Greiner Bio-One North America, Inc.
Product: VACUETTE TUBE 4 ml FX Sodium Fluoride/Potassium Oxalate, Item #454297, 13x75 grey cap-black ring, non-ridged.
Product code: JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Reason for recall: 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.
Root cause tag: software
FDA root cause: Software design
Action: 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.
Quantity in commerce: 495,600 tubes
Distribution: US Nationwide distribution in the states of CT, FL, IA, IL, MO, NC, NY, PA, TN, and VA.
Product codes and lots: Lot #A221135N, Exp. date 03/02/2024, UDI-DI Case label 39120017575130, UDI Rack label 29120017575133.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0733-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0733-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-01-24	2024-01-16

Product code JKA

K971239Class IIGreiner Vacuette Blood Collection TubeGreiner America, Inc. / cleared 1997-05-12

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)