Exact FDA event identifier

Event 84243

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket: February 19, 2019
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: The Binding Site Group, Ltd.

Dossier provenance

Source snapshots represented here

openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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 amount of injury to body tissues and for evaluation of infection, tissue injury, and inflammatory disorders. This test should be used in conjunction with other laboratory and clinical findings. The Optilite C-Reactive Protein Calibrator is intended for the calibration of the Optilite C-Reactive Protein Reagent on the Optilite analyser. The Optilite C-Reactive Protein Controls are intended for use in quality control by monitoring accuracy and precision for the Optilite C-Reactive Protein Reagent.

Z-0671-2020

Recall number: Z-0671-2020
Initiated: February 19, 2019
Classification: Class II
Status: Terminated
Recalling firm: The Binding Site Group, Ltd.
Quantity: 10 kits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Deterioration of C-reactive protein (CRP) reagent in Optilite C-Reactive Protein Kits

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Material/Component Contamination

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Inspect official wording and provenance

Reason for recall

Deterioration of C-reactive protein (CRP) reagent in Optilite C-Reactive Protein Kits

Code information

Model Number: NK044.OPT.A Lot 437705 UDI 05051700018449 Medical Device Listing number D317086

Distribution pattern

US Nationwide distribution in the states of CA and GA. OUS not provided due to product being manufacture OUS