Date Initiated by Firm | August 25, 2021 |
Create Date | October 19, 2021 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-0150-2022 |
Recall Event ID |
88627 |
Product Classification |
Anti-factor Xa activity test system, Apixaban - Product Code QLU
|
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 |
Code Information |
All currently released lots and future lots |
Recalling Firm/ Manufacturer |
Instrumentation Laboratory 180 Hartwell Rd Bedford MA 01730-2443
|
For Additional Information Contact | SAME 781-861-4467 |
Manufacturer 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
|
FDA Determined Cause 2 | 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 in Commerce | 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 |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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