RecallRadar

FDA Device recall Z-0736-2016

HemosIL Plasminogen, Part No. 0020009000, IVD. Instrumentation Laboratory Company

On 2016-02-10 the FDA classified a Class II recall of HemosIL Plasminogen, Part No. 0020009000, IVD. Instrumentation Laboratory Company by Instrumentation Laboratory, citing this Lot is not meeting labeled on-board instrument stability claims of 5 days.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0736-2016
ClassificationClass II
Statusterminated
Initiated2015-12-18
Published2016-02-10
Last updated2026-09-13 11:54 UTC
CompanyInstrumentation Laboratory
Distributionn/a

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

Reason

This Lot is not meeting labeled on-board instrument stability claims of 5 days.

Identifiers

code_infoLot No. N0455811, Expiration Date 03/31/2017

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0736-2016%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.