FDAMay 13, 2015device
Optilite Analyser, Product Code: IE700 Product Usage: The Thermo Scientific Indiko Clinical Chemistry Analyzer is a fully automated random access analyzer used to measure a variety of analytes that may be adaptable to the analyzer depending on the reagent used. The Indiko Glucose (H-K) test syste...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Potential risk of the Optilite lid/cover falling suddenly and causing injury when not placed in the fully open position.
What to do
FDA enforcement status: Terminated
Brands named
binding sitebinding
UPCs
864000290243864000290832864000290244864000290833864000290330864000290834864000290447864000290836864000290448864000290837864000290449864000290838
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDABrand Name: EXENT Analyser Product Name: EXENT Analyser Model/Catalog Number: IE800.A Software Version: 1.0.20 Product Description: The EXENT Analyser is an automated analyser intended for the qualitative and quantitative in vitro measurement of analytes in human body fluids used in conjunction w...2026-04-16
- FDAEmbrace Drill Tower, Wedged (25mm); Item Number: 645-081/62;2026-02-11
- FDAEmbrace Drill Tower, Standard/Lateral (25mm); Item Number: 645-081/63;2026-02-11
- FDAEndo-Model Replacement Plateau; Item Number: 15-0027/12;2026-01-12
- FDAEndo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/02;2026-01-12
- FDAEndo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/07;2026-01-12
- FDAEndo-Model Replacement Plateau; Item Number: 15-2835/12;2026-01-12
- FDAEndo-Model Replacement Plateau; Item Number: 15-2836/11;2026-01-12
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