FDAFebruary 19, 2019device
Optilite C-Reactive Protein Kit - Product Usage: The Optilite C-Reactive Protein Reagent is intended for the quantitative in vitro determination of C-reactive protein (CRP) concentration in serum using the Binding Site Optilite analyser. Measurement of C-Reactive Protein aids in evaluation of the...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Deterioration of C-reactive protein (CRP) reagent in Optilite C-Reactive Protein Kits
What to do
FDA enforcement status: Terminated
Brands named
binding sitebinding
UPCs
05051700018449
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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- 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 SL Connection Component incl. PE-Plateau; Item Number: 16-2840/07;2026-01-12
- FDAEndo-Model Replacement Plateau; Item Number: 15-2836/11;2026-01-12
- FDAEndo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/02;2026-01-12
- FDAEndo-Model Replacement Plateau; Item Number: 15-2835/12;2026-01-12
- FDAEndo-Model Replacement Plateau; Item Number: 15-0027/12;2026-01-12
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