Access Immunoassay Systems AFP QC, Part Number: 33219 The Access AFP QC is intended for monitoring system performance of
FDA device recall Z-2208-2010 · posted 2010-08-11 · Terminated
Recall details
- Recalling firm
- Beckman Coulter Inc.
- Reason for recall
- The recall was initiated after Beckman Coulter confirmed an issue with the Access AFP QC kits (REF 33219) which contain three levels of control material identified as QC1, QC2, and QC3, Beckman Coulter has confirmed that vials of QC1 in the kit lots identified above contain microbial contamination. Customers may see that the results from a contaminated vial of QC1 are within the established refere
- Action taken
- A Product Corrective Action (PCA) letter was sent on the week of April 19, 2010 to all customers who purchased the Access Immunoassay Systems AFP QC material, lot numbers referenced above. The letter provided the customers with an explanation of the problem identified and instructed the customers to (1) Please discard all remaining inventory of the three Access AFP QC kit lots identified above, including all vials of QC1, QC2, and QC3. (2) Please review your ac and patient results obtained while using the affected control lots. Interpret Access AFP test results in light of the clinical presentation of the patient, including: symptoms, clinical history, data from other tests and other appropriate information. (3) Please share this information with your laboratory staff and retain this notification as part of your laboratory Quality System documentation. (4) Complete and return the enclosed response form within 10 days so we can be assured that you have received this important notification. For customers that need assistance or have any questions regarding this notification, they were instructed to contact Technical Support at 1-800-854-3633 in the United States and Canada.
- Root cause
- Other
- Status
- Terminated
- Product code
- JJX
- Quantity affected
- 166
- Distribution
- Nationwide and Canada
- Date initiated
- 2010-04-21
- Date posted
- 2010-08-11
- Date terminated
- 2012-05-07
- Location
- Brea, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ACCESS AFP QC ON THE ACCESS IMMUNOASSAY ANALYZER, MODEL NUMBER 33219 (K981864) | Beckman Coulter, Inc. | 1998-06-12 |