FDAApril 9, 2020device
The Optilite Clinical Chemistry Analyzer. IVD. Model Number: IE700. UDI-05051700017176 - Product Usage: The Optilite 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.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
A software issue that may affect the analyzer's result accuracy.
What to do
FDA enforcement status: Terminated
Brands named
binding sitebinding
UPCs
05051700017176
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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- 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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