Cholestech LDX High Sensitivity C-Reactive Protein (hs-CRP) Test Cassette. The Cholestech LDX high sensitivity C-Reactiv
FDA device recall Z-2457-2008 · posted 2008-09-20 · Terminated
Recall details
- Recalling firm
- Cholestech Corp
- Reason for recall
- Test results are high, outside of control material upper limit specification. Results could be as high as 15%.
- Action taken
- Cholestech provided its three distributors a notification letter/response form with instructions to distribute the letter to their customers/end users dated August 9, 2006. The letter instructed customers to discontinue use of the lot of cassettes, return remaining cassettes to Cholestech through the Technical Service Representative and to complete and return the response form. The end users returned the signed letters directly to Cholestech so that effectiveness checks could be completed.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- DCK
- Quantity affected
- 2, 910 cassettes
- Distribution
- Nationwide Distribution --- including states of Virginia, Texas and North Carolina, Ohio, Arkansas, Washington, Florida , California and Michigan.
- Date initiated
- 2006-08-09
- Date posted
- 2008-09-20
- Date terminated
- 2009-09-30
- Location
- Hayward, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CHOLETECH LDX HIGH-SENSITIVITY C-REACTIVE PROTEIN (HS-CRP) (K040579) | Cholestech Corp. | 2004-06-18 |