Class II recall Z-0200-2027: Greiner Bio-One North America, Inc.
Class II recall Z-0200-2027: Greiner Bio-One North America, Inc. (North Carolina): Greiner Bio-One North America, Inc. Dated 8 days ago, it is in the active follow-up window. Score 68/100. As of 2026-11-04, from U.S. FDA openFDA (510(k) clearances and device enforcement reports).
Data as of · Compiled by Zalwin from U.S. FDA openFDA (510(k) clearances and device enforcement reports)
Free preview: all 14 published fields of this record are shown below. Locked: 8 related NC FDAPulse records and the 5-column CSV export.
| 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 |
| Peer records CSV (9 NC records) | 🔒 Click to unlock → |
| CRM-ready export with official source URLs | 🔒 Click to unlock → |
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CSV columns: Record · Specialty · Date · Review days · Recall class · official source URL
- Source agency: U.S. FDA openFDA (510(k) clearances and device enforcement reports)
- Record date: 2026-10-28
- Data refreshed: 2026-11-04
- Refunds on request within 14 days
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LIVE PUBLIC DATA Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) · Last refreshed: Wed, 04 Nov 2026 09:16:12 GMT
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Peer benchmark and outreach value: Class II recall Z-0200-2027: Greiner Bio-One North America, Inc. and 9 North Carolina peers
- North Carolina FDAPulse records like this one: 9
- Timing: Medium: dated in the last 30 days
- Estimated pipeline if you contact every North Carolina peer: $1,800 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
68 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- Class II recall: usually triggers CAPA and quality-system remediation work.
- Recall is still ongoing.
- Posted 8 days ago.
What is the FDAPulse record for Class II recall Z-0200-2027: Greiner Bio-One North America, Inc. in North Carolina?
Class II device recall Z-0200-2027 by Greiner Bio-One North America, Inc.: Lot B26043FM may include EDTA contamination which introduces potassium while chelating calcium in patient samples, leadi
How does Class II recall Z-0200-2027: Greiner Bio-One North America, Inc. compare to other North Carolina FDAPulse records?
It is fresh: dated 8 days ago, inside the window where early outreach matters most.
Class II recall Z-0200-2027 vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| Class II recall Z-0200-2027 | NC | 2026-10-28 |
| Class II recall Z-3155-2026 | MA | 2026-10-07 |
| Class II recall Z-0232-2027 | 2026-10-28 | |
| Class II recall Z-0243-2027 | 2026-10-28 |
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