IMx Sirolimus Reagent Pack; list 5C91-21; 100 test pack containing 1 bottle (9.7 mL) Anti-Sirolimus Antibody Coated Micr
FDA device recall Z-0501-2007 · posted 2007-02-15 · Terminated
Recall details
- Recalling firm
- Abbott Laboratories MPG
- Reason for recall
- The sirolimus values may shift higher after storage at 2-8C or after one freeze/thaw cycle of specimens.
- Action taken
- Abbott initiated a field correction recall by letter dated 8/11/06 to all customers receiving the affected reagent. The accounts were informed of the shift in sample values after storage at 2-8*C or with freeze thaw of specimens with the affected lots of reagents. The accounts were requested to review the revised sample handling information included in the attachment to the letter with their laboratory personnel and retain a copy of the letter and attachment for their records. Customers requiring additional information were directed to contact Abbott Customer Service at 1-877-422-2688.
- Root cause
- Other
- Status
- Terminated
- Product code
- NRP
- Quantity affected
- 2,800 kits
- Distribution
- Worldwide, including USA, Puerto Rico, Poland, Croatia, Latvia, Estonia, Serbia & Montenegro, Japan, Turkey, Singapore, China, India, Taiwan, Thailand, South Africa, South Korea, Australia, New Zealan
- Date initiated
- 2006-08-11
- Date posted
- 2007-02-15
- Date terminated
- 2008-01-18
- 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 IMX SIROLIMUS MICROPARTICLE ENZYME IMMUNOASSAY (K042411) | Axis-Shield , Ltd. | 2005-04-07 |