Class III recall Z-0162-2027: Magellan Diagnostics, Inc.
Class III recall Z-0162-2027: Magellan Diagnostics, Inc. (Massachusetts): Magellan Diagnostics, Inc. Dated 14 days ago, it is in the active follow-up window. Score 52/100. 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: 40 related MA FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | Device recall |
| Recall number | Z-0162-2027 |
| Recalling firm | Magellan Diagnostics, Inc. |
| Classification | Class III |
| Status | Ongoing |
| Voluntary / mandated | Voluntary: Firm initiated |
| Specialty | Other |
| Product | LeadCare II Blood Lead Test Kit. Model/Catalog Number: 70-6762. |
| Reason | In kit sub-lot 2530M-01 the date of expiration printed on the outer labeling may indicate the wrong expiration date of July 22, 2026 while the correct expiration date is July 13, 2026. If used the system will display an error message and prevent the operator from running the test. Resulting in delayed results. |
| Quantity | 321 units |
| Distribution | US Nationwide distribution in the states of CA, IN, PA, TX, NE, IL, MA, MO, KY. |
| Recall initiated | 2026-09-04 |
| Reported | 2026-10-21 |
| Firm location | North Billerica, MA, United States |
| Peer records CSV (41 MA records) | 🔒 Click to unlock → |
| CRM-ready export with official source URLs | 🔒 Click to unlock → |
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- Source agency: U.S. FDA openFDA (510(k) clearances and device enforcement reports)
- Record date: 2026-10-21
- 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 III recall Z-0162-2027: Magellan Diagnostics, Inc. and 41 Massachusetts peers
- Massachusetts FDAPulse records like this one: 41
- Timing: Medium: dated in the last 30 days
- Estimated pipeline if you contact every Massachusetts peer: $8,200 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
52 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- Class III recall: lower risk.
- Recall is still ongoing.
- Posted 14 days ago.
What is the FDAPulse record for Class III recall Z-0162-2027: Magellan Diagnostics, Inc. in Massachusetts?
Class III device recall Z-0162-2027 by Magellan Diagnostics, Inc.: In kit sub-lot 2530M-01 the date of expiration printed on the outer labeling may indicate the wrong expiration date of J
How does Class III recall Z-0162-2027: Magellan Diagnostics, Inc. compare to other Massachusetts FDAPulse records?
It is fresh: dated 14 days ago, inside the window where early outreach matters most.
Class III recall Z-0162-2027 vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| Class III recall Z-0162-2027 | MA | 2026-10-21 |
| Class III recall Z-0109-2027 | NJ | 2026-10-14 |
| Class III recall Z-0110-2027 | NJ | 2026-10-14 |
| Class III recall Z-0069-2027 | NC | 2026-10-14 |
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