Instrumentation Laboratory recalls

Instrumentation Laboratory appears in 77 official U.S. recall notices indexed by RecallRadar.

Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.

• Hemosll ReadiPlasTin (20 ml Size), Part Number 0020301400
  FDA Device · Class II · 2018-03-14 · Instrumentation Laboratory
  Reason: Instrumentation Laboratory Co. received customer reports of performance issues with some vials of Lot Nos. N1166235 and N0177760, including increased imprecision, out of range quality controls and prolonged sample resul…
• HemosIL Plasminogen, Part No. 0020009000, IVD. Instrumentation Laboratory Company
  FDA Device · Class II · 2016-02-10 · Instrumentation Laboratory
  Reason: This Lot is not meeting labeled on-board instrument stability claims of 5 days.
• HemosIL PT-Fibrinogen HS PLUS, IVD --- Instrumentation Laboratory IL Company
  FDA Device · Class II · 2014-12-31 · Instrumentation Laboratory
  Reason: Some vials of HemosIL PT-Fibrinogen HS PLUS, Part No. 0008469810 (various lots manufactured prior to June 2014) exhibit a yellow/brownish color after reconstitution (yellow color or darker) instead of the typical white…
• ACL TOP 700 LAS, automated coagulation laboratory instrument
  FDA Device · Class II · 2014-07-23 · Instrumentation Laboratory
  Reason: Potential for sample misidentification.
• ACL TOP 300 CTS, automated coagulation laboratory instrument
  FDA Device · Class II · 2014-07-23 · Instrumentation Laboratory
  Reason: Potential for sample misidentification.
• ACL TOP CTS, automated coagulation laboratory instrument
  FDA Device · Class II · 2014-07-23 · Instrumentation Laboratory
  Reason: Potential for sample misidentification.
• ACL TOP 700 CTS, automated coagulation laboratory instrument
  FDA Device · Class II · 2014-07-23 · Instrumentation Laboratory
  Reason: Potential for sample misidentification.
• ACL TOP 700, automated coagulation laboratory instrument
  FDA Device · Class II · 2014-07-23 · Instrumentation Laboratory
  Reason: Potential for sample misidentification.
• ACL TOP 500 CTS, automated coagulation laboratory instrument
  FDA Device · Class II · 2014-07-23 · Instrumentation Laboratory
  Reason: Potential for sample misidentification.
• ACL TOP (Base), automated coagulation laboratory instrument
  FDA Device · Class II · 2014-07-23 · Instrumentation Laboratory
  Reason: Potential for sample misidentification.
• HemosIL Low Abnormal Control 2 UNASSAYED Part Number: 0020003220
  FDA Device · Class II · 2013-12-25 · Instrumentation Laboratory
  Reason: HemosIL Low, Abnormal, Normal Controls UNASSAYED (no-value assigned) lacks 510(k) approval
• HemosIL Normal Control 1 UNASSAYED Part Number: 0020003120
  FDA Device · Class II · 2013-12-25 · Instrumentation Laboratory
  Reason: HemosIL Low, Abnormal, Normal Controls UNASSAYED (no-value assigned) lacks 510(k) approval
• HemosIL High Abnormal Control 3 UNASSAYED Part Number: 0020003320
  FDA Device · Class II · 2013-12-25 · Instrumentation Laboratory
  Reason: HemosIL Low, Abnormal, Normal Controls UNASSAYED (no-value assigned) lacks 510(k) approval
• ACL TOP 700 LAS
  FDA Device · Class II · 2013-09-25 · Instrumentation Laboratory
  Reason: Potential carryover issue that can can cause shortened APTT clotting times on the instrument.
• ACL TOP 300 and ACL TOP 300 CTS (Japan)
  FDA Device · Class II · 2013-09-25 · Instrumentation Laboratory
  Reason: Potential carryover issue that can can cause shortened APTT clotting times on the instrument.
• ACL TOP 700
  FDA Device · Class II · 2013-09-25 · Instrumentation Laboratory
  Reason: Potential carryover issue that can can cause shortened APTT clotting times on the instrument.
• ACL TOP CTS
  FDA Device · Class II · 2013-09-25 · Instrumentation Laboratory
  Reason: Potential carryover issue that can can cause shortened APTT clotting times on the instrument.
• ACL TOP 700 CTS
  FDA Device · Class II · 2013-09-25 · Instrumentation Laboratory
  Reason: Potential carryover issue that can can cause shortened APTT clotting times on the instrument.
• ACL TOP (Base)
  FDA Device · Class II · 2013-09-25 · Instrumentation Laboratory
  Reason: Potential carryover issue that can can cause shortened APTT clotting times on the instrument.
• ACL TOP 500 CTS
  FDA Device · Class II · 2013-09-25 · Instrumentation Laboratory
  Reason: Potential carryover issue that can can cause shortened APTT clotting times on the instrument.
• HemosIL RecombiPlasTin 2G, Part Number 0020002950 (8 ml size)
  FDA Device · Class II · 2013-07-31 · Instrumentation Laboratory
  Reason: Instrumentation Laboratory is recalling HemosIL RecombiPlasTin 2G (RPT2G), Part No. 0020009580 (8 mL Size) due to being Out of Specification.
• Instrumentation Laboratory ACL TOP 700 PN 0000280010 ACL TOP is a bench top, fully automated, random access analyzer designed specifically…
  FDA Device · Class II · 2012-09-26 · Instrumentation Laboratory
  Reason: Low Abnormal Fibrinogen Sample Reports as Normal and High Fibrinogen Sample Reports as Low
• Instrumentation Laboratory ACL TOP (Base) PN 0000280000 ACL TOP is a bench top, fully automated, random access analyzer designed specifical…
  FDA Device · Class II · 2012-09-26 · Instrumentation Laboratory
  Reason: Low Abnormal Fibrinogen Sample Reports as Normal and High Fibrinogen Sample Reports as Low
• Instrumentation Laboratory ACL TOP 500 CTS PN 0000280040 ACL TOP is a bench top, fully automated, random access analyzer designed specifica…
  FDA Device · Class II · 2012-09-26 · Instrumentation Laboratory
  Reason: Low Abnormal Fibrinogen Sample Reports as Normal and High Fibrinogen Sample Reports as Low
• Instrumentation Laboratory ACL TOP 700 LAS PN 0000280030 ACL TOP is a bench top, fully automated, random access analyzer designed specifica…
  FDA Device · Class II · 2012-09-26 · Instrumentation Laboratory
  Reason: Low Abnormal Fibrinogen Sample Reports as Normal and High Fibrinogen Sample Reports as Low
• Instrumentation Laboratory ACL TOP CTS PN 0000280020 ACL TOP is a bench top, fully automated, random access analyzer designed specifically…
  FDA Device · Class II · 2012-09-26 · Instrumentation Laboratory
  Reason: Low Abnormal Fibrinogen Sample Reports as Normal and High Fibrinogen Sample Reports as Low
• Instrumentation Laboratory ACL TOP 700 CTS PN 0000280050 ACL TOP is a bench top, fully automated, random access analyzer designed specifica…
  FDA Device · Class II · 2012-09-26 · Instrumentation Laboratory
  Reason: Low Abnormal Fibrinogen Sample Reports as Normal and High Fibrinogen Sample Reports as Low