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Instrumentation Laboratory Recalls

77 recalls on record · September 26, 2012 to August 12, 2026 · Medical Devices

Recalls by year

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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.

December 25, 2013Medical DevicesFDA
Instrumentation Laboratory Co. recalls HemosIL High Abnormal Control 3 UNASSAYED Part Number: 0020003320
Hazard: HemosIL Low, Abnormal, Normal Controls UNASSAYED (no-value assigned) lacks 510(k) approval
December 25, 2013Medical DevicesFDA
Instrumentation Laboratory Co. recalls HemosIL Low Abnormal Control 2 UNASSAYED Part Number: 0020003220
Hazard: HemosIL Low, Abnormal, Normal Controls UNASSAYED (no-value assigned) lacks 510(k) approval
December 25, 2013Medical DevicesFDA
Instrumentation Laboratory Co. recalls HemosIL Normal Control 1 UNASSAYED Part Number: 0020003120
Hazard: HemosIL Low, Abnormal, Normal Controls UNASSAYED (no-value assigned) lacks 510(k) approval
September 25, 2013Medical DevicesFDA
Instrumentation Laboratory Co. recalls ACL TOP 500 CTS; PN 0000280040 Bench top, fully automated, random access analyzer designed specifically for in vitro
Hazard: Potential carryover issue that can can cause shortened APTT clotting times on the instrument.
September 25, 2013Medical DevicesFDA
Instrumentation Laboratory Co. recalls ACL TOP 300 and ACL TOP 300 CTS (Japan); PN 0000280060 Bench top, fully automated, random access analyzer designed sp
Hazard: Potential carryover issue that can can cause shortened APTT clotting times on the instrument.
September 25, 2013Medical DevicesFDA
Instrumentation Laboratory Co. recalls ACL TOP 700 CTS; PN 0000280050 Bench top, fully automated, random access analyzer designed specifically for in vitro
Hazard: Potential carryover issue that can can cause shortened APTT clotting times on the instrument.
September 25, 2013Medical DevicesFDA
Instrumentation Laboratory Co. recalls ACL TOP 700 LAS; PN 0000280030 Bench top, fully automated, random access analyzer designed specifically for in vitro
Hazard: Potential carryover issue that can can cause shortened APTT clotting times on the instrument.
September 25, 2013Medical DevicesFDA
Instrumentation Laboratory Co. recalls ACL TOP CTS; PN 0000280020 Bench top, fully automated, random access analyzer designed specifically for in vitro diag
Hazard: Potential carryover issue that can can cause shortened APTT clotting times on the instrument.
September 25, 2013Medical DevicesFDA
Instrumentation Laboratory Co. recalls ACL TOP 700; PN 0000280010 Bench top, fully automated, random access analyzer designed specifically for in vitro diag
Hazard: Potential carryover issue that can can cause shortened APTT clotting times on the instrument.
September 25, 2013Medical DevicesFDA
Instrumentation Laboratory Co. recalls ACL TOP (Base); PN 0000280000 Bench top, fully automated, random access analyzer designed specifically for in vitro d
Hazard: Potential carryover issue that can can cause shortened APTT clotting times on the instrument.
July 31, 2013Medical DevicesFDA
Instrumentation Laboratory Co. recalls HemosIL RecombiPlasTin 2G, Part Number 0020002950 (8 ml size). The product is used for the evaluation of the extrinsic c
Hazard: Instrumentation Laboratory is recalling HemosIL RecombiPlasTin 2G (RPT2G), Part No. 0020009580 (8 mL Size) due to being Out of Specification.
September 26, 2012Medical DevicesFDA
Instrumentation Laboratory Co. recalls Instrumentation Laboratory ACL TOP 700 CTS PN 0000280050 ACL TOP is a bench top, fully automated, random access an
Hazard: Low Abnormal Fibrinogen Sample Reports as Normal and High Fibrinogen Sample Reports as Low
September 26, 2012Medical DevicesFDA
Instrumentation Laboratory Co. recalls Instrumentation Laboratory ACL TOP 500 CTS PN 0000280040 ACL TOP is a bench top, fully automated, random access an
Hazard: Low Abnormal Fibrinogen Sample Reports as Normal and High Fibrinogen Sample Reports as Low
September 26, 2012Medical DevicesFDA
Instrumentation Laboratory Co. recalls Instrumentation Laboratory ACL TOP 700 LAS PN 0000280030 ACL TOP is a bench top, fully automated, random access an
Hazard: Low Abnormal Fibrinogen Sample Reports as Normal and High Fibrinogen Sample Reports as Low
September 26, 2012Medical DevicesFDA
Instrumentation Laboratory Co. recalls Instrumentation Laboratory ACL TOP CTS PN 0000280020 ACL TOP is a bench top, fully automated, random access analyze
Hazard: Low Abnormal Fibrinogen Sample Reports as Normal and High Fibrinogen Sample Reports as Low
September 26, 2012Medical DevicesFDA
Instrumentation Laboratory Co. recalls Instrumentation Laboratory ACL TOP 700 PN 0000280010 ACL TOP is a bench top, fully automated, random access analyzer
Hazard: Low Abnormal Fibrinogen Sample Reports as Normal and High Fibrinogen Sample Reports as Low
September 26, 2012Medical DevicesFDA
Instrumentation Laboratory Co. recalls Instrumentation Laboratory ACL TOP (Base) PN 0000280000 ACL TOP is a bench top, fully automated, random access analy
Hazard: Low Abnormal Fibrinogen Sample Reports as Normal and High Fibrinogen Sample Reports as Low