Access Immunoassay Systems, 862.2160 discrete photometric chemistry analyzer.
This recall has been terminated (originally issued November 30, 2004).
- Company
- Beckman Coulter Inc.
- Recall Initiated
- November 8, 2004
- Posted
- November 30, 2004
- Terminated
- August 13, 2012
- Recall Number
- Z-0265-05
- Quantity
- 1,197
- Firm Location
- Brea, CA
- Official Source
- View on FDA website ↗
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.
Distribution
Nationwide and Canada
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.
Root Cause
Other
Action Taken
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.