Lp(a) Diluent packaged into 60 mL bottles, Catalog #23817, Lot #s 238017-01 & 238017-03; 480 mL bulk catalog # 95046B, L
FDA device recall Z-0636-05 · posted 2005-03-18 · Terminated
Recall details
- Recalling firm
- Diasorin Inc.
- Reason for recall
- QC testing of the Antibody Reagent Set for Lp(a) SPQ Test System it was discovered that the background was failing high of the specification. Through substitution testing it was determined that the Lp(a) diluent, part #238017 was the cause of the failing background specification.
- Action taken
- Customers were sent notification letters and instructed to destroy any remaining inventory. Customers were also requested to return a form which indicates number of kits destroyed and a replacement was offered.
- Root cause
- Other
- Status
- Terminated
- Product code
- DFC
- Quantity affected
- 631 as individual vials, 1 bulk unit and 401 sold in kits
- Distribution
- KC, MO, CA, IN, HI, GA, TX, MN, ME, AZ, FL, VA, MI, NJ, NC, NY, CO, WI, MS, BRUSSELS, GREECE, SWEDEN, ENGLAND, SPAIN, CANADA & SWITZERLAND
- Date initiated
- 2005-01-10
- Date posted
- 2005-03-18
- Date terminated
- 2006-07-22
- 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 |
|---|---|---|
| SPQ TEST SYSTEM (K982708) | DiaSorin, Inc. | 1999-04-02 |