Instrumentation Laboratory Co. Recalls

All product recalls associated with Instrumentation Laboratory Co..

Get alerts for this brand

Recall Summary

Total Recalls

17

Past Year

0

Class I (Serious)

0

Most Recent

Jul 2019

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 1–17 of 17 recalls

ROTEM ex-tem (Instrumentation Laboratory) – Clotting Time Issue (2019)

Prolonged clotting times

Moderate

FDAJul 23, 2019IL, MI, WI• Instrumentation Laboratory Co.

ROTEM ex-tem (Instrumentation Laboratory) – Clotting Time Issue (2019)

Prolonged clotting times

Moderate

FDAJul 23, 2019IL, MI, WI• Instrumentation Laboratory Co.

ROTEM ex-tem (Instrumentation Laboratory) – Clotting Time Issue (2019)

Prolonged clotting times

Moderate

FDAJul 23, 2019IL, MI, WI• Instrumentation Laboratory Co.

HemosIL PT-Fibrinogen (Instrumentation Laboratory) – Color Change (2014)

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 to off-white color. Vials exhibiting this yellow/brownish color were observed to cause prolonged prothrombin (PT) clotting times.

Class IIModerate

FDANov 21, 2014Nationwide• Instrumentation Laboratory Co.

ACL TOP CTS, automated coagulation laboratory instrument. (Instrumentation Laboratory Co.) – potential for sample misidentification (2014)

Potential for sample misidentification.

Class IIModerate

FDAJun 3, 2014Nationwide• Instrumentation Laboratory Co.

HemosIL Low Abnormal Control 2 UNASSAYED Part Number: 00... (Instrumentation Laboratory Co.) – hemosil low, abnormal, normal control... (2013)

HemosIL Low, Abnormal, Normal Controls UNASSAYED (no-value assigned) lacks 510(k) approval

Class IIModerate

FDANov 15, 2013Nationwide• Instrumentation Laboratory Co.

ACL TOP Coagulation Analyzer (Instrumentation Laboratory) – Liquid Contamination (2007)

ACL TOP unit, when in emergency stop may release liquid during recovery sequence and contaminate sample tube.

Low

FDAJun 19, 2007Nationwide• Instrumentation Laboratory Co.

GEM Premier 4000 Analyzer (Instrumentation Laboratory) – Sampling Mode Error (2007)

Instrument in Micro Sampling Mode failed to aspirate and no error code was generated and an incorrect patient report could result

Moderate

FDAMar 27, 2007Nationwide• Instrumentation Laboratory Co.

Hemoliance RecombiPlasTin (Instrumentation Laboratory) – Antibiotic Interference (2006)

Firm received 2 complaints concerning incorrect prothrombin time (PT) results while using the reagents on samples of patients taking the antibiotic CUBICIN (Daptomycin for injection).

Moderate

FDAMar 7, 2006Nationwide• Instrumentation Laboratory Co.

HemosIL RecombiPlasTin (Instrumentation Laboratory) – Antibiotic Interference (2006)

Firm received 2 complaints concerning incorrect prothrombin time (PT) results while using the reagents on samples of patients taking the antibiotic CUBICIN (Daptomycin for injection).

Moderate

FDAMar 7, 2006Nationwide• Instrumentation Laboratory Co.

GEM PREMIER 3000 (Instrumentation Laboratory) – Software Calculation Error (2005)

Software error may report higher results for glucose and lactate

Moderate

FDADec 16, 2005Nationwide• Instrumentation Laboratory Co.

Coagulation Analyzers (Instrumentation Laboratory) – PT Reporting Error (2005)

Patient prothrombin time (PT) may report low for individuals on anticoaglant therapy

Moderate

FDAMay 19, 2005Nationwide• Instrumentation Laboratory Co.

ACL Advance Analyzer (Instrumentation Laboratory) – Software Reagent Issue (2004)

Software may cause instrument to omit step causing reagent carrover which may effect patient test result

High

FDAMar 4, 2004FL• Instrumentation Laboratory Co.

ACL Futura Analyzer (Instrumentation Laboratory) – Software Reagent Issue (2004)

Software may cause instrument to omit step causing reagent carrover which may effect patient test result

High

FDAMar 4, 2004FL• Instrumentation Laboratory Co.

Lactate Membrane Caps (Instrumentation Laboratory) – Result Bias (2003)

Lactate Disposable Membrane Caps linearity was determined to be significantly biased and could potentially cause erroneous patient results above 6.0 mmol/L.

Moderate

FDAAug 28, 2003IL, NY• Instrumentation Laboratory Co.

GEM Premier 3000 Pak (Instrumentation Lab) – Bar Code Error (2003)

Incorrect bar code applied to cartridges could result in inaccurate pO2 value

Low

FDAMar 7, 2003CA, FL, NY +2 more• Instrumentation Laboratory Co.

GEM Premier 3000 Pak (Instrumentation Lab) – Bar Code Error (2003)

Incorrect bar code applied to cartridges could result in inaccurate pO2 value

Low

FDAMar 7, 2003CA, FL, NY +2 more• Instrumentation Laboratory Co.

Stay Informed

Instrumentation Laboratory Co. Recalls

Recall Summary

ROTEM ex-tem (Instrumentation Laboratory) – Clotting Time Issue (2019)

ROTEM ex-tem (Instrumentation Laboratory) – Clotting Time Issue (2019)

ROTEM ex-tem (Instrumentation Laboratory) – Clotting Time Issue (2019)

HemosIL PT-Fibrinogen (Instrumentation Laboratory) – Color Change (2014)

ACL TOP CTS, automated coagulation laboratory instrument. (Instrumentation Laboratory Co.) – potential for sample misidentification (2014)

HemosIL Low Abnormal Control 2 UNASSAYED Part Number: 00... (Instrumentation Laboratory Co.) – hemosil low, abnormal, normal control... (2013)

ACL TOP Coagulation Analyzer (Instrumentation Laboratory) – Liquid Contamination (2007)

GEM Premier 4000 Analyzer (Instrumentation Laboratory) – Sampling Mode Error (2007)

Hemoliance RecombiPlasTin (Instrumentation Laboratory) – Antibiotic Interference (2006)

HemosIL RecombiPlasTin (Instrumentation Laboratory) – Antibiotic Interference (2006)

GEM PREMIER 3000 (Instrumentation Laboratory) – Software Calculation Error (2005)

Coagulation Analyzers (Instrumentation Laboratory) – PT Reporting Error (2005)

ACL Advance Analyzer (Instrumentation Laboratory) – Software Reagent Issue (2004)

ACL Futura Analyzer (Instrumentation Laboratory) – Software Reagent Issue (2004)

Lactate Membrane Caps (Instrumentation Laboratory) – Result Bias (2003)

GEM Premier 3000 Pak (Instrumentation Lab) – Bar Code Error (2003)

GEM Premier 3000 Pak (Instrumentation Lab) – Bar Code Error (2003)