Instrumentation Laboratory recalls HemosIL Liquid Anti-Xa- for reduced on-board instrument stability from 7 to 5 days. Affected units may cause inaccurate heparin measurements.
“HemosIL Liquid Anti-Xa- Recall: Reduced Instrument Stability Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61899-hemosil-liquid-anti-xa-recall-reduced-instrument-stability-risk. Based on FDA recall #Z-0151-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0151-2022%22&limit=1).
The Food and Drug Administration announced on 2021-08-25 that Instrumentation Laboratory is recalling HemosIL Liquid Anti-Xa- assay kits due to reduced on-board instrument stability, which may affect test results. The agency issued recall number Z-0151-2022 for the Class II device.
How to tell if you have it
Brand: Instrumentation Laboratory
Product: HemosIL Liquid Anti-Xa-
Part Number: 0020302601
Quantity: 40,224 units
The hazard
The recall addresses a labeled on-board instrument stability issue for current and future lots of the assay. This defect reduces the on-board instrument stability from 7 days to 5 days.
Context
GovInfoNow's records show Instrumentation Laboratory has 13 other recalls on record since 2021-10-13. Recent brand recalls include a GEM Premier 5000 PAK lysing bag solution risk reported on 2026-05-21 and patient ID errors with GEM Premier 5000/7000 blood analyzers announced on 2026-05-08. Other recent recalls of similar products include Siemens Healthcare Syva EMIT 2000 Quinidine Assay (2026-07-13), Aniara Diagnostica 5-PLASMA Bivalirudin Kit (2026-07-01), and HEMOSPRAY Endoscopic Hemostat (2026-08-20).
How to tell if you have this one
Check for the HemosIL Liquid Anti-Xa- product on ACL TOP Family 50 Series or ACL Elite/Elite Pro systems. All currently released lots and future lots are affected.
Brand
Instrumentation Laboratory
Category
Medical device
FDA recall event · 3 products
All 3 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Ongoing
Distribution
US Nationwide Foreign: Canada Armenia Austria Australia Belgium Brunei Brazil Belarus Switzerland China Colombia Czech Republic Germany Denmark Spain Finland France United Kingdom Gibraltar Greece Hong Kong Hungary Indonesia Ireland Israel India Iran Italy¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿¿ Japan South Korea Kuwait Kazakhstan Lebanon Sri Lanka Lithuania Luxembourg Macau Mexico Malaysia Netherlands Poland Portugal Qatar Reunion Romania Serbia Russia Saudi Arabia Sweden Thailand Tunisia Turkey Taiwan Vietnam Zambia
Recall number
Product, codes & lots
Quantity
Z-0149-2022
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, (ACL TOP¿ Family, ACL TOP Family 50 Seriest and ACL Elite¿/Elite Pro/8/9/10000) Part Number: 0020302600; All currently released lots and future lots
64,114
Z-0150-2022
HemosIL Liquid Anti-Xa- automated chromogenic assay for in vitro diagnostic use by laboratory professionals in clinical laboratories. The assay provides quantitative results on 3.2% citrated human plasma Part Number: 0020302602; All currently released lots and future lots
25,738 US
Z-0151-2022
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; All currently released lots and future lots
40,224
Based on the official FDA remedy
What to do — step by step
Check Product Details
Identify if your HemosIL Liquid Anti-Xa- is on ACL TOP Family 50 Series or ACL Elite/Elite Pro systems.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “US Nationwide Foreign: Canada Armenia Austria Australia Belgium Brunei Brazil Belarus Switzerland China Colombia Czech Republic Germany Denmark Spain Finland France United Kingdom Gibraltar Greece Hong Kong Hungary Indonesia Ireland Israel…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 2 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0151-2022 (August 25, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0151-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.