Recall Z-0537-05 ยท CDD Radioassay, Vitamin B12
Diagnostic Products Corp
IMMULITE 2000 Vitamin B12 Kit, Catalog # L2KVB2, L2KVB6, kit lot 186.
| Date | Feb 11, 2005 (initiated Jan 24, 2005) |
| Status | Terminated |
| Reason | A low CPS limit was not incorporated in the kit barcode for IMMULITE 2000 Vitamin B12 L2KVB 2, 6 kit lot 186 only. |
| Root cause | Other |
| Action | 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. |
| Quantity | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K993251 | IMMULITE 2000 VITAMIN B12, MODEL L2KVB2, L2KVB6 Diagnostic Products Corp., Nov 17, 1999 |