Z-0149-2022Class II

HemosIL Liquid Anti-Xa- Automated chromogenic assay for the quantitative determination of unfractionated...

Name: Z-0149-2022 HemosIL Liquid Anti-Xa- Automated chromogenic assay for the quantitative determination of unfractionated...
Creator: Instrumentation Laboratory
Published: 2021-08-25
License: https://open.fda.gov/license/

Instrumentation Laboratory Co. / initiated 2021-08-25 / Open, Classified / root cause: design

FDA source

Instrumentation Laboratory began a recall of HemosIL Liquid Anti-Xa- Automated chromogenic assay for the quantitative determination of unfractionated heparin (UFH) and low molecular weight heparin (LMWH)... on 2021-08-25. FDA classified it as Class II and gives the reason as "Labeled On-board instrument stability issue for current and future lots, reduced On-board Instrument Stability from 7 days to 5 days". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-0149-2022
Classification: Class II
Status: Open, Classified
Initiated: 2021-08-25
Posted: 2021-10-19
Recalling firm: Instrumentation Laboratory Co.
Product: 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
Product code: KFF Assay, Heparin
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
Root cause tag: design
FDA 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: [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
Quantity in commerce: 64,114
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
Product codes and lots: All currently released lots and future lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0149-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0149-2022	Class II	Ongoing	Voluntary: Firm initiated	2021-10-27	2021-10-19
Z-0150-2022	Class II	Ongoing	Voluntary: Firm initiated	2021-10-27	2021-10-19
Z-0151-2022	Class II	Ongoing	Voluntary: Firm initiated	2021-10-27	2021-10-19

Product code KFF

K090209Class IIHemosil Liquid Heparin, Heparin Calibrators and Lmw and Uf Heparin ControlsInstrumentation Laboratory CO / cleared 2009-06-02

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)