Device recall: ACL TOP (Base); PN 0000280000 Bench top, fully automated, random access analyzer designed specifically for in vitro…

Class II FDA enforcement event 65893. Recall start date: 19 Jul 2013. Status in the FDA record: Terminated. Termination date: 27 Oct 2014.

Reason for recall, in the words of FDA

Potential carryover issue that can can cause shortened APTT clotting times on the instrument.

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 19 Jul 2013. The firm address in the FDA record is in Bedford, MA. FDA put the recall in Class II. FDA event 65893 has 7 product records. The first FDA enforcement report date is 25 Sep 2013. The record gives the status Terminated, with the termination date 27 Oct 2014.

FDA enforcement report The 7 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 including AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX,…

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

7 product records in the event.

FDA event 65893: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-2244-2013	ACL 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…	929	Class II	Terminated	25 Sep 2013
Z-2245-2013	ACL TOP 700; PN 0000280010 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…	311	Class II	Terminated	25 Sep 2013
Z-2246-2013	ACL TOP CTS; PN 0000280020 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…	486	Class II	Terminated	25 Sep 2013
Z-2247-2013	ACL TOP 700 LAS; PN 0000280030 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…	56	Class II	Terminated	25 Sep 2013
Z-2248-2013	ACL TOP 700 CTS; PN 0000280050 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…	185	Class II	Terminated	25 Sep 2013
Z-2249-2013	ACL TOP 300 and ACL TOP 300 CTS (Japan); PN 0000280060 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…	662	Class II	Terminated	25 Sep 2013
Z-2250-2013	ACL TOP 500 CTS; PN 0000280040 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…	2170	Class II	Terminated	25 Sep 2013

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 2013: 1,236
Share of these events in Class II: 90%
Product records in this event: 7Median 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
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
3 Aug 2012	Instrumentation Laboratory ACL TOP (Base) PN 0000280000 ACL TOP is a bench top, fully automated, random access analyzer	Device	Class II	6

Instrumentation Laboratory Co.: all 10 events

Official channels

FDA enforcement report Z-2244-2013The 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.

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Cite this page

Recall Register. FDA enforcement event 65893. https://recallregister.com/fda/ii/65893/. 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 including AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX,…
What quantity of product is in FDA event 65893?: The event has 7 product records. The first record gives this quantity: 929
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2013 have the same class?: 90% of the 1,236 device events that started in 2013 are in Class II.