Recall Z-0150-2022 ยท QLU Anti-Factor Xa Activity Test System, Apixaban
Instrumentation Laboratory
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
| Date | Aug 25, 2021 |
| Status | Open, Classified |
| Reason | Labeled On-board instrument stability issue for current and future lots, reduced On-board Instrument Stability from 7 days to 5 days |
| Root cause | Device Design |
| Action | Werfen issued Urgent Medical Device Correction letter via email via email or registered mail on 9/7/21. Letter states reason for recall, health risk and action to take: NOTE: Please refer to the separate "URGENT Medical Device Removal" notice (dated August 25, 2021) for Hemosll Liquid Anti-Xa, Part No. 0020302600, which removes claims for this assay from the ACL Elite and ACL Elite Pro instruments. " Mandatory Customer Actions At this time, the on-board instrument stability claim has been reduced from 7 days to 5 days for all in-date and future product lots of Hemosll Liquid Anti-Xa (Part Nos |
| Quantity | 25,738 US |
| 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 Gree |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.