Recall Register

Instrumentation Laboratory Co.: FDA recalls

FDA enforcement reports name Instrumentation Laboratory Co. as the recalling firm in 10 events. The events have 31 product records. The recalls started from 2012 to 2019. All the events are device recalls.

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.

FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .

Enforcement events

10 events, newest first.

FDA enforcement events of Instrumentation Laboratory Co.
InitiatedProduct (first record)TypeClassRecordsStatus
23 Jul 2019ROTEM ex-tem; US Part No: 503-05-USDeviceClass II3Terminated
1 Aug 2018Hemosll ReadiPlasTin (10 mL Size), Part Number 0020301300 - Product Usage - HemosIL ReadiPlasTin is an in vitro diagnostic thromboplastin reagent, based on recombinant human tissue factor, for the quantitative determination, in human citrated plasma, of Prothrombin Time (PT) and Fibrinogen, on the ACL TOP Family of…DeviceClass II1Terminated
2 Aug 2017Hemosll ReadiPlasTin (20 ml Size), Part Number 0020301400DeviceClass II1Terminated
18 Dec 2015HemosIL Plasminogen, Part No. 0020009000, IVD. Instrumentation Laboratory Company. Kit contents: 2 x 2.5 mL Streptokinase reagent and 2 x 2 mL Chromogenic substrateDeviceClass II1Terminated
21 Nov 2014HemosIL PT-Fibrinogen HS PLUS, IVD --- Instrumentation Laboratory IL Company. A high sensitivity thromboplastin reagent based on recombinant human tissue factor (RTF) for the quantitative determination in human citrated plasma of Prothrombin Time (PT) and Fibrinogen on IL Coagulation Systems. The product is used for…DeviceClass II1Terminated
3 Jun 2014ACL TOP (Base), automated coagulation laboratory instrument.DeviceClass II7Terminated
15 Nov 2013HemosIL Normal Control 1 UNASSAYED Part Number: 0020003120DeviceClass II3Terminated
19 Jul 2013ACL TOP (Base); PN 0000280000 Bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems provide results for both direct hemostasis…DeviceClass II7Terminated
9 Apr 2013HemosIL RecombiPlasTin 2G, Part Number 0020002950 (8 ml size). The product is used for the evaluation of the extrinsic coagulation pathway and the monitoring of Oral Anticoagulant Therapy.DeviceClass II1Terminated
3 Aug 2012Instrumentation Laboratory ACL TOP (Base) PN 0000280000 ACL TOP is a bench top, fully automated, random access analyzer designed specifically for in vitro diagnostic clinical use in the hemostasis laboratory for coagulation and/or fibrinolysis testing in the assessment of thrombosis and/or hemostasis. The systems…DeviceClass II6Terminated

An event with 1 product record and a class that is not Class I has no page. It has a row in this table.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Recalling firm: The firm that the FDA record names for a recall.

Type and class

Instrumentation Laboratory Co.: events for each product type
TypeEvents
Device10
Instrumentation Laboratory Co.: events in each class
ClassEvents
Class II10
Share of the events of the firm in Class I
0%
Share of all events on the register in Class I
18%
Events with the status Ongoing
0

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Events by year

FDA enforcement events of Instrumentation Laboratory Co., by the year that the recall started. The largest year is 2013, with 3 events.

Official channels

Cite this page

Recall Register. Instrumentation Laboratory Co.: FDA recalls. https://recallregister.com/firm/instrumentation-laboratory-co/. Source: openFDA enforcement reports. Data through .

Sources

Source
openFDA enforcement reports
Licence
CC0 1.0
Export date
28 Sep 2026
State of the firm address
MA

The firm name is the spelling in the FDA records. A company with 2 spellings has 2 pages.

A firm with more products can have more recalls. This site does not compare one firm with a different firm. How the register is made. Report an error.

Questions

Which classes do the FDA recalls of Instrumentation Laboratory Co. have?
Class II: 10 events. The class is for the product of a recall. It is not a class of the firm.
What is the newest FDA recall of Instrumentation Laboratory Co.?
FDA event 83523, which the firm started on 23 Jul 2019. The first product in the record is: ROTEM ex-tem; US Part No: 503-05-US
How many FDA recalls of Instrumentation Laboratory Co. have the status Ongoing?
No event has the status Ongoing in the openFDA file. openFDA says about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.