# Class I recall Z-0001-2027: Instrumentation Laboratory

**Predicate Speed & CAPA Advisory Opportunity Score:** 76/100

| Field | Value |
|---|---|
| Record | Device recall |
| Recall number | Z-0001-2027 |
| 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: 0009800127. in vitro diagnostic |
| Reason | Potential for invalid calibration curve or negative mean bias of up to 47% with patient samples. |
| Quantity | 434 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 |

## Why this score
- Class I recall: the most serious category, typically requiring urgent corrective and preventive action (CAPA).
- Recall is still ongoing.
- Posted 15 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-0001-2027%22). Last refreshed: 2026-11-04T09:16:12.111Z.
Data from the FDA openFDA API, which may lag official FDA databases. Informational only; not regulatory or legal advice.