Agency classClass IIOur severity:High FDA (Devices)·Z-0150-2022·Announced 2021-10-27

Anti-Xa Assay On-Board Stability Reduced from 7 to 5 Days

The HemosIL Liquid Anti-Xa diagnostic assay has reduced on-board stability from 7 days to 5 days. Laboratories should follow updated stability guidelines for all currently released and future lots.

The agency’s classification

FDA (Devices): Class II

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.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a risk-of-harm product (critical anticoagulation diagnostic) where reduced reagent stability could affect test accuracy. No illnesses or injuries have been reported to date, which caps the score at 3.

Plain-English summary

Instrumentation Laboratory is recalling the HemosIL Liquid Anti-Xa automated chromogenic assay due to a labeling correction for on-board instrument stability. The validated on-board stability period has been reduced from 7 days to 5 days for all currently released lots and future lots.

The HemosIL Liquid Anti-Xa assay is an in vitro diagnostic used by clinical laboratories to monitor anticoagulation therapy. The assay provides quantitative results on 3.2% citrated human plasma. Approximately 25,738 units have been distributed in the United States, with additional distribution to over 40 countries worldwide.

Laboratories using this assay should immediately review and implement the updated on-board stability specifications. The reagent should not be used beyond 5 days on the instrument. Labs should update their standard operating procedures and quality control measures to ensure compliance with the corrected stability guidelines.

The recalled product

Product: 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
Manufacturer: Instrumentation Laboratory
Category: Medical Device — In Vitro Diagnostic
Hazard: mis-labeling
diagnostic-inaccuracy
Affected units: 25,738

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

All currently released lots and future lots

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 recalled by Instrumentation Laboratory under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Same manufacturer · Instrumentation Laboratory

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