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

Recall number

Z-0150-2022

Recalling firm

Instrumentation Laboratory

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

Status

Open, Classified

Initiated

2021-08-25

Posted

not on file

Terminated

not on file

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. 0020302600 and 0020302602) on the ACL TOP Family and ACL TOP Family 50 Series. Please take the following immediate actions: " Use the following reduced on-board instrument stability claim for Hemosll Liquid Anti-Xa (Part Nos. 0020302600 and 0020302602) on the ACL TOP Family and ACL TOP Family 50 Series. ACL TOP Family and ACL TOP Family 50 Series Current On-board Instrument Stability Reduced On-board Instrument Stability 7 Days 5 Days " Run quality controls before patient testing or every 8 hours and with each new vial in accordance with good laboratory practice. " Post this notification on each of your ACL TOP Family and ACL TOP Family 50 Series instruments. " Share this information with your staff, notifying them of the reduced on-board stability requirement of 5 Days for the ACL TOP Family and ACL TOP Family 50 Series. " Retain a copy of this letter in your files as a record of the notification. " Complete and return the enclosed Mandatory Response Tracking Form to acknowledge the above actions. " Return the completed and signed form immediately to: " Fax No.: 781-861-4207 " E-mail: ra-usa.na@werfen.com NOTE: Please return the tracking form even if you do not have any inventory of Hemosll Liquid Anti-Xa (Part Nos. 0020302600 and 0020302602). " Contact Information for Questions " For technical questions, please contact the Technical Support Center at 1-8

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 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

Lot, serial or model codes

All currently released lots and future lots

510(k) numbers

not on file

PMA numbers

not on file

Product code

QLU

Firm FEI

1217183

Firm city

Bedford

Firm state

MA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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