FDA Device recall Z-1020-2025
HemosIL Heparin Calibrators
- FDA Device
- Class II
- ongoing
- Published 2025-02-05
On 2025-02-05 the FDA classified a Class II recall of HemosIL Heparin Calibrators by Instrumentation Laboratory, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1020-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-12-18 |
| Published | 2025-02-05 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Instrumentation Laboratory |
| Distribution | US |
Product
HemosIL Heparin Calibrators; Part Number: 0020300600; in vitro diagnostic
Reason
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.
Identifiers
| code_info | Part Number: 0020300600; UDI-DI: 08426950472483; Lot Numbers: N0128933, N0220450, N0522479, N0724070, N1026509, N023958…Part Number: 0020300600; UDI-DI: 08426950472483; Lot Numbers: N0128933, N0220450, N0522479, N0724070, N1026509, N0239584, N0531891, N0733658, N0249207, N0442161, N0744673; ****Lot numbers added 4/15/2026**** N0531891, N0733658, N0249207, N0442161, N0744673, N1147734, N020463, N0250464, N0452277, N0553155, N0754506; |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1020-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.