Beckman Coulter Inc Access Immunoassay Systems, 862.2160 discrete photometric chemistry analyzer. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Access Immunoassay Systems, 862.2160 discrete photometric chemistry analyzer.
Brand
Beckman Coulter Inc
Lot Codes / Batch Numbers
Access 2 Immunoassay Systems Part Number 81600N software versions 20., 2.1, and 2.2. Access Immunoassay Systems Chlamydia Reagent Kit Part Number 34401.
Products Sold
Access 2 Immunoassay Systems Part Number 81600N software versions 20., 2.1, and 2.2. Access Immunoassay Systems Chlamydia Reagent Kit Part Number 34401.
Beckman Coulter Inc is recalling Access Immunoassay Systems, 862.2160 discrete photometric chemistry analyzer. due to 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 unde. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026