Recall Z-0921-2010 ยท DCK C-Reactive Protein, Antigen, Antiserum, And Control
Beckman Coulter Inc
IMMAGE Immunochemistry Systems C-Reactive Protein (CRP) Reagent, Part Number 447280. Intended for the quantitative determination of C-Reactive Protein (CRP) in human serum or plasma by rate nephelometry.
| Date | Mar 2, 2010 (initiated Jan 10, 2008) |
| Status | Terminated |
| Reason | IMMAGE CRP Reagent lots M705441, M709279, & M709319, may demonstrate a prozone or hook effect on samples with extremely high CRP analyte concentration. |
| Root cause | Other |
| Action | Customers were sent Urgent: Product Corrective Action letters dates, 1/22/2008. The letter identified the issue, discussed the impact, and listed the following actions/resolution. * To eliminate the hook effect when using these lots, run CRP samples beginning with the 1:216 dilution. ~ A limited correlation of patient samples run in the 1:36 dilution compared to the same samples run in the 1:216 dilution verifies acceptable performance (there may be a shift of up to 0.8 mg/dL for samples between 1.0 and 8.0 mg/dL). * Controls run in the 1:216 dilution may recover differentl |
| Quantity | 878 kits |
| Distribution | Nationwide Distribution -- Including states of AL, CA, CT, DC, FL, FL ,GA, HI, IA, IL ,IN, KY ,MA, MD, ME, MI, MO, NE, NJ, NY, OH, OR, PA, RI, TX, VA, WI, and WV. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K981638 | IMMAGE IMMUNOCHEMISTRY SYSTEM C-REACTIVE PROTEIN (CRP) REAGENT Beckman Coulter, Inc., Jun 12, 1998 |