Z-0200-2027

Brand Name: VACUETTE Product Name: LH Lithium Heparin Separator Model/Catalog Number: 454008P Product...

Name: Z-0200-2027 Brand Name: VACUETTE Product Name: LH Lithium Heparin Separator Model/Catalog Number: 454008P Product...
Creator: Greiner Bio-One North America, Inc.
Published: 2026-07-29
License: https://open.fda.gov/license/

Greiner Bio-One North America, Inc. / initiated 2026-07-29 / Open, Classified

FDA source

Recall record

Recall number: Z-0200-2027
Status: Open, Classified
Initiated: 2026-07-29
Posted: 2026-10-21
Recalling firm: Greiner Bio-One North America, Inc.
Product: Brand Name: VACUETTE Product Name: LH Lithium Heparin Separator Model/Catalog Number: 454008P Product Description: Greiner VACUETTE Blood Collection Tube with Lithium Heparin and Gel Separator (13 x 75 mm, 3.5ml)
Product code: JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Reason for recall: Lot B26043FM may include EDTA contamination which introduces potassium while chelating calcium in patient samples, leading to falsely elevated potassium (K+) and falsely decreased calcium (Ca++) results which have the potential to cause hyperkalemia.
FDA root cause: Nonconforming Material/Component
Action: On 07/29/2026, an "URGENT MEDICAL DEVICE RECALL NOTICE" was emailed to customers informing them that, Greiner Bio-One North America identified a potential ethylenediaminetetraacetic acid (EDTA) contamination issue in a specific lot of VACUETTE Lithium Heparin serum separator tubes. Use of affected tubes may lead to: " Falsely elevated potassium (K+) results " Falsely decreased calcium (Ca++) results Customers are instructed to: " Immediately identify and quarantine all remaining units of item 454008P, lot B26043FM. " Stop using the affected lot for blood collection. " Notify relevant staff (phlebotomy, lab, clinical teams) of this advisory. " Review any recent patient results obtained using this lot. Consider repeat testing with a different lot if results appear inconsistent with clinical presentation. " Follow proper order of draw, and recollection procedures when re-testing. For unused product disposal (if destroyed by customer/distributor) " The unused blood collection tubes contain chemical additives (LH and serum separator). Recommend following OSHA process, and/or your facility's environmental health and safety (EHS) policies and procedures for disposal. For questions or documentation (Acknowledgement and Receipt Form) to [email protected] or please call 800-515-8112.
Quantity in commerce: 860450
Distribution: U.S. Nationwide distribution in the states of CO, FL, IL, MO, NE, NY, OH, PA, and VA.
Product codes and lots: Lot Code: Item Number: 454008P Lot Number: B26043FM UDI: Rack: 29120017579032, Case: 39120017579039 Expiration Date: 2027-07-12

Product code JKA

K960857Class IIGreiner Vacuette Blood Collection Tube W/lithium Heparin & Gel SeparatorGreiner America, Inc. / cleared 1996-08-30

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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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-10-23. View this recall on fda.gov (opens on fda.gov)