The Recall Desk

Manufacturer

Instrumentation Laboratory Co.

31 recalls in our database name Instrumentation Laboratory Co. as the manufacturing or recalling firm.

What the numbers show

Total
31
Critical
0
Severe
1
Most recent
2019-09-18

Of the 31 recalls from Instrumentation Laboratory Co. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (3%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–25 of 31

  • ModerateFDA (Devices)·Z-0077-2019·2018-10-17

    Instrumentation Laboratory Recalls HemosIL ReadiPlasTin Diagnostic Reagent

    Instrumentation Laboratory is recalling 9,751 kits of HemosIL ReadiPlasTin due to potential imprecision and out-of-range quality controls.

    Product
    Hemosll 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) an
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0895-2018·2018-03-14

    Instrumentation Laboratory Recalls Hemosll ReadiPlasTin Kits Due to Performance Issues

    Instrumentation Laboratory is recalling 14,894 Hemosll ReadiPlasTin kits due to reported performance issues, including increased imprecision and out-of-range quality controls.

    Product
    Hemosll ReadiPlasTin (20 ml Size), Part Number 0020301400
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0736-2016·2016-02-10

    Instrumentation Laboratory Recalls HemosIL Plasminogen IVD Kits

    Instrumentation Laboratory is recalling specific lots of HemosIL Plasminogen kits because they do not meet labeled stability claims.

    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
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0832-2015·2014-12-31

    Instrumentation Laboratory Recalls HemosIL PT-Fibrinogen HS PLUS Reagent

    Instrumentation Laboratory is recalling HemosIL PT-Fibrinogen HS PLUS reagent kits because some vials exhibit discoloration that causes prolonged prothrombin clotting times.

    Product
    HemosIL 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 Coag
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2060-2014·2014-07-23

    Instrumentation Laboratory Recalls ACL TOP Coagulation Instruments

    Instrumentation Laboratory Co. is recalling 1,074 ACL TOP (Base) automated coagulation laboratory instruments due to a potential for sample misidentification.

    Product
    ACL TOP (Base), automated coagulation laboratory instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2062-2014·2014-07-23

    Instrumentation Laboratory Recalls ACL TOP CTS Coagulation Instruments

    Instrumentation Laboratory is recalling 572 ACL TOP CTS automated coagulation laboratory instruments due to a potential for sample misidentification.

    Product
    ACL TOP CTS, automated coagulation laboratory instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2064-2014·2014-07-23

    Instrumentation Laboratory Recalls ACL TOP 500 CTS Coagulation Instruments

    Instrumentation Laboratory is recalling ACL TOP 500 CTS automated coagulation laboratory instruments due to a potential for sample misidentification.

    Product
    ACL TOP 500 CTS, automated coagulation laboratory instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2066-2014·2014-07-23

    Instrumentation Laboratory Recalls ACL TOP 300 CTS Coagulation Instruments

    Instrumentation Laboratory Co. is recalling ACL TOP 300 CTS automated coagulation laboratory instruments due to a potential for sample misidentification.

    Product
    ACL TOP 300 CTS, automated coagulation laboratory instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2065-2014·2014-07-23

    Instrumentation Laboratory Recalls ACL TOP 700 CTS Coagulation Instruments

    Instrumentation Laboratory is recalling 266 ACL TOP 700 CTS automated coagulation laboratory instruments due to a potential for sample misidentification.

    Product
    ACL TOP 700 CTS, automated coagulation laboratory instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2063-2014·2014-07-23

    Instrumentation Laboratory Recalls ACL TOP 700 LAS Coagulation Instruments

    Instrumentation Laboratory is recalling 99 ACL TOP 700 LAS automated coagulation laboratory instruments due to a potential for sample misidentification.

    Product
    ACL TOP 700 LAS, automated coagulation laboratory instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2061-2014·2014-07-23

    Instrumentation Laboratory Recalls ACL TOP 700 Coagulation Instruments

    Instrumentation Laboratory is recalling 633 ACL TOP 700 automated coagulation laboratory instruments due to a potential for sample misidentification.

    Product
    ACL TOP 700, automated coagulation laboratory instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0515-2014·2013-12-25

    Instrumentation Laboratory Recalls HemosIL Low Abnormal Control 2 Kits

    Instrumentation Laboratory is recalling 6,504 kits of HemosIL Low Abnormal Control 2 UNASSAYED because the product lacks FDA 510(k) approval.

    Product
    HemosIL Low Abnormal Control 2 UNASSAYED Part Number: 0020003220
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2244-2013·2013-09-25

    Instrumentation Laboratory Recalls ACL TOP Analyzers Due to Carryover Issue

    Instrumentation Laboratory is recalling 929 ACL TOP analyzers because a potential carryover issue may cause shortened APTT clotting times.

    Product
    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 p
    Category
    Medical Device
    Distribution
    46 states
  • HighFDA (Devices)·Z-2248-2013·2013-09-25

    Instrumentation Laboratory ACL TOP 700 CTS Analyzer Recall for Carryover Issue

    Instrumentation Laboratory is recalling 185 ACL TOP 700 CTS analyzers due to a potential carryover issue that may cause shortened APTT clotting times.

    Product
    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
    Category
    Medical Device
    Distribution
    46 states
  • HighFDA (Devices)·Z-2250-2013·2013-09-25

    Instrumentation Laboratory ACL TOP 500 CTS Recall for Carryover Issue

    Instrumentation Laboratory is recalling ACL TOP 500 CTS analyzers due to a potential carryover issue that may cause shortened APTT clotting times.

    Product
    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
    Category
    Medical Device
    Distribution
    46 states
  • HighFDA (Devices)·Z-2247-2013·2013-09-25

    Instrumentation Laboratory Recalls ACL TOP 700 LAS Analyzers for Carryover Issue

    Instrumentation Laboratory is recalling 56 ACL TOP 700 LAS analyzers due to a potential carryover issue that can cause shortened APTT clotting times.

    Product
    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
    Category
    Medical Device
    Distribution
    46 states
  • HighFDA (Devices)·Z-2249-2013·2013-09-25

    Instrumentation Laboratory ACL TOP 300 Analyzers Recalled for Carryover Issue

    Instrumentation Laboratory is recalling 662 ACL TOP 300 and ACL TOP 300 CTS analyzers worldwide due to a potential carryover issue that may cause shortened APTT clotting times.

    Product
    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
    Category
    Medical Device
    Distribution
    46 states
  • HighFDA (Devices)·Z-2246-2013·2013-09-25

    Instrumentation Laboratory Recalls ACL TOP CTS Analyzers Due to Carryover Issue

    Instrumentation Laboratory is recalling 486 ACL TOP CTS analyzers because a potential carryover issue may cause shortened APTT clotting times.

    Product
    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 prov
    Category
    Medical Device
    Distribution
    46 states
  • HighFDA (Devices)·Z-2245-2013·2013-09-25

    Instrumentation Laboratory Recalls ACL TOP 700 Analyzers for Carryover Issue

    Instrumentation Laboratory is recalling 311 ACL TOP 700 analyzers due to a potential carryover issue that may cause shortened APTT clotting times.

    Product
    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 prov
    Category
    Medical Device
    Distribution
    46 states
  • ModerateFDA (Devices)·Z-1784-2013·2013-07-31

    Instrumentation Laboratory Recalls HemosIL RecombiPlasTin 2G Coagulation Reagent

    Instrumentation Laboratory is recalling HemosIL RecombiPlasTin 2G reagent kits due to out-of-specification quality issues. The product is used for evaluating the extrinsic coagulation pathway.

    Product
    HemosIL 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.
    Category
    Medical Device
    Distribution
    Distributed nationwide

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

INSTRUMENTATION LABORATORY COMPANY

Source: Wikidata (Q138457451), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.