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Open, Classified

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

FDA Recall Z-0149-2022 · Posted None

Recalling FirmInstrumentation Laboratory
Recall StatusOpen, Classified
Product CodeKFF
Date Initiated2021-08-25
Product Quantity64,114

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

Firm 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: [email protected] 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

Root Cause

Device Design

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K090209HEMOSIL LIQUID HEPARIN, HEPARIN CALIBRATORS AND LMW AND UF HEPARIN CONTROLSInstrumentation Laboratory CO · 2009-06-02

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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