ARCHITECT Folate Low and Medium Controls, List 6C12-10; the kit contains 2 - 8 mL vials, Low Control L 2.5 ng/mL and Med
FDA device recall Z-0361-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Abbott Laboratories HPD/ADD/GPRD
- Reason for recall
- The is an increase in the number of control values out of range low, and diluted patient specimens may yield lower than expected results.
- Action taken
- Abbott notified their international affiliates via e-mail on 12/16/03 and 1/5/04. Device recall letters dated 12/16/03 and 12/31/03 will be sent to the end users by the affiliates, informing them of the unapproved serum albumin used to manufacture the folate products, and listing the impact to performance for each affected components. There are separate customer recall letters for each assay platform -- ARCHITECT, AxSYM and IMx.
- Root cause
- Other
- Status
- Terminated
- Product code
- CGN
- Quantity affected
- 720 kits
- Distribution
- There was no U.S. distribution. The products were shipped internationally through Abbott affiliates in Canada, Germany, Singapore, Hong Kong, Australia, Brazil, New Zealand, Columbia, Chile, Uruguay,
- Date initiated
- 2003-12-16
- Date posted
- 2004-07-20
- Date terminated
- 2004-07-20
- Location
- Abbott Park, IL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ABBOTT ARCHITECT FOLATE (K023397) | Abbott Laboratories | 2002-12-16 |