Recall Z-0151-2022— Instrumentation Laboratory
Class II · Ongoing
Class II FDA medical device recall by Instrumentation Laboratory, initiated 2021-08-25. FDA's recall record names no specific 510(k) clearance for this event. Product: HemosIL Liquid Anti-Xa- Automated chromogenic assay for the quantitative determination of unfractionated heparin (UFH) and low molecular weight heparin (LMWH) activity in human citrated plasma on IL Coagulation Systems, (ACLTOP¿ Family, ACL TOP Family 50 Seriest and ACL Elite¿/Elite Pro) Part Number: 0020302601. Reason: Labeled On-board instrument stability issue for current and future lots, reduced On-board Instrument Stability from 7 days to 5 days.
- Recalling firm
- Instrumentation Laboratory
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2021-08-25
- Firm location
- Bedford, MA, United States
Product description
HemosIL Liquid Anti-Xa- Automated chromogenic assay for the quantitative determination of unfractionated heparin (UFH) and low molecular weight heparin (LMWH) activity in human citrated plasma on IL Coagulation Systems, (ACLTOP¿ Family, ACL TOP Family 50 Seriest and ACL Elite¿/Elite Pro) Part Number: 0020302601
Reason for recall
Labeled On-board instrument stability issue for current and future lots, reduced On-board Instrument Stability from 7 days to 5 days
Data sourced from openFDA. This site is unofficial and independent of the FDA.