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CDS-LTX PRIMER

CLINICAL DIAGNOSTIC SOLUTIONS, INC. · Model 6 x 16mL · UDI-DI 00812137010261

510(k) clearances

Adverse events

Recalls

Facilities

Description

CDS-LTX Primer is used to prepare the tubing and instrument components on the COULTER HmX/MAXM, STKS and GEN-S instruments prior to analyzing CDS LTX Control. The Coulter HmX/MAXM, STKS and GEN-S instruments require a clean sample line prior to aspirating CDS LTX-Control. Otherwise, performance might be adversely affected through increased coefficients of variation for the volume, conductivity and light scatter parameters.

Recalls

Date	Firm	Reason
2006-09-18	Abbott Laboratories	Potential for on-market instability in the whole blood calibrator which could lead to inaccurate platelet (PLT) test results.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.