Access Immunoassay Systems, 862.2160 discrete photometric chemistry analyzer.
FDA device recall Z-0265-05 · posted 2004-11-30 · Terminated
Recall details
- Recalling firm
- Beckman Coulter Inc
- 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.
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- CGN
- Quantity affected
- 1,197
- Distribution
- Nationwide and Canada
- Date initiated
- 2004-11-08
- Date posted
- 2004-11-30
- Date terminated
- 2012-08-13
- Location
- Brea, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ACCESS THEOPHYLLINE IMMUNOASSAY REAGENTS (K922823) | Bio-Rad Laboratories, Inc. | 1992-08-05 |