—#35834

Product

Access Immunoassay Systems, 862.2160 discrete photometric chemistry analyzer.

FDA product code: CGN — Acid, Folic, Radioimmunoassay
Device class: Class 2
Medical specialty: Clinical Chemistry
510(k) numbers: K922823
Affected lot / code info: Access 2 Immunoassay Systems Part Number 81600N software versions 20., 2.1, and 2.2. Access Immunoassay Systems Chlamydia Reagent Kit Part Number 34401.

Why it was recalled

A rare condition of the Access 2 Immunoassay Systems software versions 2.0, 2.1 and 2.2 could present a risk of an erroneous confirmatory result under a specific set of circumstances. The Chlamydia Blocking results may be affected. The instrument will erroneously perform the blocking calculation on the affected test by using the mean of the diluted and neat results.

Root cause (FDA determination)

Other

Action the firm took

Product Corrective Action (PCA) letter that informs customers (who ordered Access Chlamydia reagent in the past 24 months and have an Access 2 Immunoassay System) of this potential issue sent via US mail on November 8, 2004. The letter instructs customers to use unique Sample IDs for all samples assayed on the system - including those which have been manipulated offline prior to assay. A Technical Information Update will be issued to inform all support personnel of this issue.

Recalling firm

Firm: Beckman Coulter Inc
Address: 200 S Kraemer Blvd, Brea, California 92822-6208

Distribution

Distribution pattern: Nationwide and Canada

Timeline

Recall initiated: 2004-11-08
Posted by FDA: 2004-11-30
Terminated: 2012-08-13
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #35834. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.