Z-0736-2016Class II

HemosIL Plasminogen, Part No. 0020009000, IVD. Instrumentation Laboratory Company. Kit contents: 2 x 2.5 mL...

Name: Z-0736-2016 HemosIL Plasminogen, Part No. 0020009000, IVD. Instrumentation Laboratory Company. Kit contents: 2 x 2.5 mL...
Creator: Instrumentation Laboratory Co.
Published: 2015-12-18
License: https://open.fda.gov/license/

Instrumentation Laboratory Co. / initiated 2015-12-18 / Terminated / root cause: design

FDA source

Instrumentation Laboratory Co. began a recall of HemosIL Plasminogen, Part No. 0020009000, IVD. Instrumentation Laboratory Company. Kit contents: 2 x 2.5 mL Streptokinase reagent and 2 x 2 mL Chromogenic... on 2015-12-18. FDA classified it as Class II and gives the reason as "This Lot is not meeting labeled on-board instrument stability claims of 5 days". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0736-2016
Classification: Class II
Status: Terminated
Initiated: 2015-12-18
Posted: 2016-02-01
Terminated: 2017-08-30
Recalling firm: Instrumentation Laboratory Co.
Product: HemosIL Plasminogen, Part No. 0020009000, IVD. Instrumentation Laboratory Company. Kit contents: 2 x 2.5 mL Streptokinase reagent and 2 x 2 mL Chromogenic substrate
Product code: GGP Test, Qualitative And Quantitative Factor Deficiency
Reason for recall: This Lot is not meeting labeled on-board instrument stability claims of 5 days.
Root cause tag: design
FDA root cause: Device Design
Action: Instrumentation Laboratory Co. sent an " Urgent Medical Device Removal" letter dated December 2015, was sent on December 18, 2015. via USPS to US and Canadian customers. The notification requires US and Canadian customers to respond using a Mandatory Response Tracking Form. A Field Safety Notice was e-mailed on December 18, 2015, to the affected IL affiliates, notifying them of the product lot removal due to a stability issue and requesting them to translate the Field Safety Notice, to notify their Competent Authorities and to provide the notification to their affected customer base and secondary distributors. For further questions, please call 1(800) 955-9525.
Quantity in commerce: Domestic: 108 kits, Foreign: 197 kits
Distribution: Worldwide Distribution - US Distribution and to the countries of : Canada, Argentina, Austria, Belgium, Brazil, China, Czech Republic, France, Germany, Hong Kong, Italy, Lithuania, Panama, Poland, Russia, Saudi Arabia, United Kingdom, and Venezuela.
Product codes and lots: Lot No. N0455811, Expiration Date 03/31/2017

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0736-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0736-2016	Class II	Terminated	Voluntary: Firm initiated	2016-02-10	2016-02-01

Product code GGP

K981200Class IIIl Test PlasminogenInstrumentation Laboratory CO / cleared 1998-05-26

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)