# Class II recall Z-0200-2027: Greiner Bio-One North America, Inc.

**Predicate Speed & CAPA Advisory Opportunity Score:** 68/100

| Field | Value |
|---|---|
| Record | Device recall |
| Recall number | Z-0200-2027 |
| Recalling firm | Greiner Bio-One North America, Inc. |
| Classification | Class II |
| Status | Ongoing |
| Voluntary / mandated | Voluntary: Firm initiated |
| Specialty | Other |
| 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) |
| Reason | 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. |
| Quantity | 860450 |
| Distribution | U.S. Nationwide distribution in the states of CO, FL, IL, MO, NE, NY, OH, PA, and VA. |
| Recall initiated | 2026-07-29 |
| Reported | 2026-10-28 |
| Firm location | Monroe, NC, United States |

## Why this score
- Class II recall: usually triggers CAPA and quality-system remediation work.
- Recall is still ongoing.
- Posted 8 days ago.

Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0200-2027%22). Last refreshed: 2026-11-04T21:30:53.898Z.
Data from the FDA openFDA API, which may lag official FDA databases. Informational only; not regulatory or legal advice.