Device recall: Instrumentation Laboratory ACL TOP (Base) PN 0000280000 ACL TOP is a bench top, fully automated, random access…

Class II FDA enforcement event 62894. Recall start date: 3 Aug 2012. Status in the FDA record: Terminated. Termination date: 2 Oct 2015.

Reason for recall, in the words of FDA

Low Abnormal Fibrinogen Sample Reports as Normal and High Fibrinogen Sample Reports as Low

Class II, in the words of FDA

a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote

Instrumentation Laboratory Co. started this device recall on 3 Aug 2012. The firm address in the FDA record is in Bedford, MA. FDA put the recall in Class II. FDA event 62894 has 6 product records. The first FDA enforcement report date is 26 Sep 2012. The record gives the status Terminated, with the termination date 2 Oct 2015.

FDA enforcement report The 6 product records

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 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

Worldwide distribution: USA (nationwide) and countries of: ARGENTINA, AUSTRALIA, AUSTRIA, BELARUS, BELGIUM, BRAZIL, BRUNEI DARUSSALAM, BULGARIA, CHILE, CHINA, DENMARK, FINLAND, FRANCE, GERMANY, HONG…

Recalling firm

Instrumentation Laboratory Co., Bedford, MA.

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

FDA records how the recall started: Voluntary: Firm initiated.

Products

6 product records in the event.

FDA event 62894: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-2387-2012	Instrumentation 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…	1074 units	Class II	Terminated	26 Sep 2012
Z-2388-2012	Instrumentation Laboratory ACL TOP 700 PN 0000280010 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…	304 units	Class II	Terminated	26 Sep 2012
Z-2389-2012	Instrumentation Laboratory ACL TOP CTS PN 0000280020 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…	562 units	Class II	Terminated	26 Sep 2012
Z-2390-2012	Instrumentation Laboratory ACL TOP 700 LAS PN 0000280030 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…	46 units	Class II	Terminated	26 Sep 2012
Z-2391-2012	Instrumentation Laboratory ACL TOP 500 CTS PN 0000280040 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…	2171 units	Class II	Terminated	26 Sep 2012
Z-2392-2012	Instrumentation Laboratory ACL TOP 700 CTS PN 0000280050 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…	140 units	Class II	Terminated	26 Sep 2012

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.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

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

Class II: The middle of the three FDA recall classes.

The event in context

Device events that started in 2012: 823
Share of these events in Class II: 88%
Product records in this event: 6Median of the firm: 3
Events of the firm on the register: 10

Other events of the firm

Other FDA enforcement events of Instrumentation Laboratory Co.
Initiated	Product (first record)	Type	Class	Records
23 Jul 2019	ROTEM ex-tem; US Part No: 503-05-US	Device	Class II	3
1 Aug 2018	Hemosll ReadiPlasTin (10 mL Size), Part Number 0020301300 - Product Usage - HemosIL ReadiPlasTin is an in vitro diagnost	Device	Class II	1
2 Aug 2017	Hemosll ReadiPlasTin (20 ml Size), Part Number 0020301400	Device	Class II	1
18 Dec 2015	HemosIL Plasminogen, Part No. 0020009000, IVD. Instrumentation Laboratory Company. Kit contents: 2 x 2.5 mL Streptokinas	Device	Class II	1
21 Nov 2014	HemosIL PT-Fibrinogen HS PLUS, IVD --- Instrumentation Laboratory IL Company. A high sensitivity thromboplastin reagent	Device	Class II	1
3 Jun 2014	ACL TOP (Base), automated coagulation laboratory instrument.	Device	Class II	7
15 Nov 2013	HemosIL Normal Control 1 UNASSAYED Part Number: 0020003120	Device	Class II	3
19 Jul 2013	ACL TOP (Base); PN 0000280000 Bench top, fully automated, random access analyzer designed specifically for in vitro diag	Device	Class II	7
9 Apr 2013	HemosIL RecombiPlasTin 2G, Part Number 0020002950 (8 ml size). The product is used for the evaluation of the extrinsic c	Device	Class II	1

Instrumentation Laboratory Co.: all 10 events

Official channels

FDA enforcement report Z-2387-2012The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

Follow by RSS:Food, drug and device recallsFDA Class I recalls

Cite this page

Recall Register. FDA enforcement event 62894. https://recallregister.com/fda/ii/62894/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA device enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: Worldwide distribution: USA (nationwide) and countries of: ARGENTINA, AUSTRALIA, AUSTRIA, BELARUS, BELGIUM, BRAZIL, BRUNEI DARUSSALAM, BULGARIA, CHILE, CHINA, DENMARK, FINLAND, FRANCE, GERMANY, HONG…
What quantity of product is in FDA event 62894?: The event has 6 product records. The first record gives this quantity: 1074 units
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2012 have the same class?: 88% of the 823 device events that started in 2012 are in Class II.