IMMULITE 2000 Vitamin B12 Kit, Catalog # L2KVB2, L2KVB6, kit lot 186.
FDA device recall Z-0537-05 · posted 2005-02-11 · Terminated
Recall details
- Recalling firm
- Diagnostic Products Corp
- Reason for recall
- A low CPS limit was not incorporated in the kit barcode for IMMULITE 2000 Vitamin B12 L2KVB 2, 6 kit lot 186 only.
- Action taken
- Domestic customers were notified on January 24, 2005, via telephone and strted receiving a fax-back form and a technical Bulletin on January 25, 2005. Foreign consignees were notified via email and/or Fax.
- Root cause
- Other
- Status
- Terminated
- Product code
- CDD
- Quantity affected
- 189 kits
- Distribution
- AL, CA, CO, FL, IL, KS, LA, NY, MA, MD, MI, MS, NC, NE, NM, OH, PA, TN, TX, UT, WA, and Australia, Czech Republic, France, Germany, Netherlands, Portugal, Puerto Rico, Sweden, Turkey, UK, Venzuela
- Date initiated
- 2005-01-24
- Date posted
- 2005-02-11
- Date terminated
- 2005-07-12
- Location
- Los Angeles, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| IMMULITE 2000 VITAMIN B12, MODEL L2KVB2, L2KVB6 (K993251) | Diagnostic Products Corp. | 1999-11-17 |