Recall Z-0150-2022— 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 in vitro diagnostic use by laboratory professionals in clinical laboratories. The assay provides quantitative results on 3.2% citrated human plasma Part Number: 0020302602. 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 in vitro diagnostic use by laboratory professionals in clinical laboratories. The assay provides quantitative results on 3.2% citrated human plasma Part Number: 0020302602
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.