Class I recall Z-0002-2027: Instrumentation Laboratory
Class I recall Z-0002-2027: Instrumentation Laboratory (Massachusetts): Instrumentation Laboratory. Dated 15 days ago, it is in the active follow-up window. Score 76/100. 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-0002-2027 |
| Recalling firm | Instrumentation Laboratory |
| Classification | Class I |
| Status | Ongoing |
| Voluntary / mandated | Voluntary: Firm initiated |
| Specialty | Other |
| Product | HemoslL AcuStar HIT-lgG(PF-4). Part Number: 0009802028. in vitro diagnostic (OUS only) |
| Reason | Potential for invalid calibration curve or negative mean bias of up to 47% with patient samples. |
| Quantity | 1,414 units |
| Distribution | Worldwide - US Nationwide distribution in the states of AR, AZ, CA, CT, FL, GA, MA, MD, NJ, NY, PA, RI, TN, WA, WV and the countries of Austria, Belgium, Switzerland, Costa Rica, Czech Republic, Germany, Denmark, Spain, Finland, France, United Kingdom, Greece, India, Italy, Jordan, Japan, South Kore |
| Recall initiated | 2026-09-03 |
| Reported | 2026-10-21 |
| Firm location | Bedford, 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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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: 2026-10-21
- 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 I recall Z-0002-2027: Instrumentation Laboratory 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)
76 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- Class I recall: the most serious category, typically requiring urgent corrective and preventive action (CAPA).
- Recall is still ongoing.
- Posted 15 days ago.
What is the FDAPulse record for Class I recall Z-0002-2027: Instrumentation Laboratory in Massachusetts?
Class I device recall Z-0002-2027 by Instrumentation Laboratory: Potential for invalid calibration curve or negative mean bias of up to 47% with patient samples.
How does Class I recall Z-0002-2027: Instrumentation Laboratory compare to other Massachusetts FDAPulse records?
It is 15 days old, still within a typical 45-day follow-up window. Its Predicate Speed & CAPA Advisory Opportunity Score of 76/100 puts it among the stronger signals in this feed.
Class I recall Z-0002-2027 vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| Class I recall Z-0002-2027 | MA | 2026-10-21 |
| Class I recall Z-0127-2027 | WA | 2026-10-28 |
| Class I recall Z-0132-2027 | WA | 2026-10-28 |
| Class I recall Z-0131-2027 | WA | 2026-10-28 |
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