Instrumentation Laboratory Co.
526 Route 303, ORANGEBURG, NY, US
Registered product codes
44 product codes
Recent MDR events
266 on file
- HEMOSIL SYNTHASILJul 10, 2026Malfunction1217183-2026-00015
- GEM PREMIER 5000Jul 9, 2026Malfunction1217183-2026-00013
- GEM PREMIER 5000Jul 9, 2026Malfunction1217183-2026-00014
- HEMOCHRON ACT MACHINEJun 29, 2026Malfunction25650350
- HEMOSIL SYNTHASILJun 23, 2026Malfunction1217183-2026-00012
- HEMOSIL SYNTHASILJun 10, 2026Malfunction1217183-2026-00011
- HEMOSIL SYNTHASILJun 3, 2026Malfunction1217183-2026-00010
- GEM PREMIER 5000May 27, 2026Malfunction1217183-2026-00009
- HEMOSIL SYNTHASILMay 19, 2026Malfunction1217183-2026-00008
- GEM PREMIER 5000May 6, 2026Malfunction1217183-2026-00006
Recalls
58 on file
- TerminatedMar 3, 2018
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 results.
View FDA record ↗ - TerminatedFeb 1, 2016
This Lot is not meeting labeled on-board instrument stability claims of 5 days.
View FDA record ↗ - TerminatedDec 19, 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.
View FDA record ↗ - TerminatedJul 16, 2014
Potential for sample misidentification.
View FDA record ↗ - TerminatedJul 16, 2014
Potential for sample misidentification.
View FDA record ↗ - TerminatedJul 16, 2014
Potential for sample misidentification.
View FDA record ↗ - TerminatedJul 16, 2014
Potential for sample misidentification.
View FDA record ↗ - TerminatedJul 16, 2014
Potential for sample misidentification.
View FDA record ↗ - TerminatedJul 16, 2014
Potential for sample misidentification.
View FDA record ↗ - TerminatedJul 16, 2014
Potential for sample misidentification.
View FDA record ↗
Compliance history
Matched by FEI 2431530.
FDA inspections
0 on file
No inspections on file for this FEI number.
Inspection citations
0 on file
No citations on file for this FEI number.
Compliance actions
0 on file
No warning letters or injunctions on file for this FEI number.
Import refusals
0 on file
No import refusals on file for this FEI number.