1,25-Dihydroxyvitamin D RIA Kit -For the quantitative determination of 1,25 Dihydroxyvitamin D in serum or EDTA plasma-D
FDA device recall Z-0707-2007 · posted 2007-04-03 · Terminated
Recall details
- Recalling firm
- Diasorin Inc.
- Reason for recall
- Potential for the DiaSorin Kit 1,25-Dihydroxyvitamin D RIA Kit Control 1 (lot 548520) & 2 (lot 548521) to recover out of the defined range, LOW. (If one or both of the kit controls recover outside the defined range, the run is considered invalid)
- Action taken
- Product recalled by letter dated 6/01/2006
- Root cause
- Other
- Status
- Terminated
- Product code
- MRG
- Quantity affected
- 715
- Distribution
- Worldwide Distribution-USA including states of UT, CO, IL, NY, NV, MI, NC, MN, VA, GA, CA, KS, VT, CT and IN, and Countries of Canada, Sweden, Germany, Belgium, Italy, France, Norway, Australia, South
- Date initiated
- 2006-06-05
- Date posted
- 2007-04-03
- Date terminated
- 2007-06-25
- Location
- Stillwater, MN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| 1,25-DIHYDROXYVITAMIN D125I RIA (K014030) | DiaSorin, Inc. | 2002-03-26 |