AxSYM Homocysteine Reagent Pack, list 5F51-20, Produced by Axis-Shield, Oslo, Norway, for Abbott Laboratories, Abbott Pa
FDA device recall Z-1218-03 · posted 2003-09-11 · Terminated
Recall details
- Recalling firm
- Abbott Laboratories HPD/ADD/GPRD
- Reason for recall
- There is a kit-to-kit difference within the lots, with the reagents generating different polarization values than those in others.
- Action taken
- Recall letters dated 8/22/03 informed users of the kit to kit difference within the lots, and outlined the actions needed to take for patient results obtained from the use of the affected kits. The customers were requested to destroy any remaining inventory of the affected reagents. Any questions were directed to Abbott's Customer Service at 1-877-422-2688.
- Root cause
- Other
- Status
- Terminated
- Product code
- LPS
- Quantity affected
- 3505 kits
- Distribution
- Lot 01724M300 was distributed nationwide, as well as to Canada, Singapore, Tahiland, Korea, Hong Kong and China. Lots 03314HN00 and 03533HN00 were distributed by Abbott's Delkenheim, Germany subsidiar
- Date initiated
- 2003-08-22
- Date posted
- 2003-09-11
- Date terminated
- 2004-07-20
- Location
- Abbott Park, IL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ABBOTT AXSYM HOMOCYSTEINE (K992858) | Abbott Laboratories | 1999-10-25 |