Food, drugs, devices › Instrumentation Laboratory
Device recall: HemosIL Heparin Calibrators; Part Number: 0020300600; in vitro diagnostic
Instrumentation Laboratory (Bedford, MA) initiated this device recall on 18 Dec 2024; FDA lists 1 product record under event 96044, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 87% of the 970 device enforcement events initiated in 2024 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. Instrumentation Laboratory has 14 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Instrumentation Laboratory, Bedford, MA.
Reason for recall
"Control indicating lower than expected quality control (QC) results and in some instances QC recovery below the lower limit of the package insert acceptance range."
Distribution
"Worldwide - US Nationwide and the countries of Andorra, Algeria, Armenia, Australia, Austria, Belarus, Belgium, Brazil, Brunei Darussalam, Bulgaria, Canada, China, Colombia, Cyprus, Czechia,…"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1020-2025 | HemosIL Heparin Calibrators; Part Number: 0020300600; in vitro diagnostic | 10,952 units (5,303 US, 5,649 OUS) (Additional 11,562 units updated 4/15/2026) | Class II | Ongoing | 5 Feb 2025 |
Context
Other enforcement events for Instrumentation Laboratory
All 14 events for Instrumentation Laboratory
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Control indicating lower than expected quality control (QC) results and in some instances QC recovery below the lower limit of the package insert acceptance range."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Worldwide - US Nationwide and the countries of Andorra, Algeria, Armenia, Australia, Austria, Belarus, Belgium, Brazil, Brunei Darussalam, Bulgaria, Canada, China, Colombia, Cyprus, Czechia,…"
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.