Recall Z-2457-2008 ยท DCK C-Reactive Protein, Antigen, Antiserum, And Control
Cholestech Corp
Cholestech LDX High Sensitivity C-Reactive Protein (hs-CRP) Test Cassette. The Cholestech LDX high sensitivity C-Reactive Protein (hs-CRP) is an in vitro diagnostic test for the quantitative determination of C-reactive protein in whole blood or serum. Measurement of CRP is useful as an aid in the detection and evaluation of infection, tissue injury, inflammatory disorders and associated diseases.
| Date | Sep 20, 2008 (initiated Aug 9, 2006) |
| Status | Terminated |
| Reason | Test results are high, outside of control material upper limit specification. Results could be as high as 15%. |
| Root cause | Device Design |
| Action | 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. |
| Quantity | 2, 910 cassettes |
| Distribution | Nationwide Distribution --- including states of Virginia, Texas and North Carolina, Ohio, Arkansas, Washington, Florida , California and Michigan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K040579 | CHOLETECH LDX HIGH-SENSITIVITY C-REACTIVE PROTEIN (HS-CRP) Cholestech Corp., Jun 18, 2004 |