Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

Access Immunoassay Systems, 862.2160 discrete photometric chemistry analyzer.

FDA Recall Z-0265-05 · Posted 2004-11-30

Recalling FirmBeckman Coulter Inc
Recall StatusTerminated
Product CodeCGN
Date Initiated2004-11-08
Date Terminated2012-08-13
Product Quantity1,197

Reason for Recall

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.

Firm Action

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.

Root Cause

Other

Distribution Pattern

Nationwide and Canada

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K922823ACCESS THEOPHYLLINE IMMUNOASSAY REAGENTSBio-Rad Laboratories, Inc. · 1992-08-05

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑