FDA Recall
Terminated
IMMULITE 2000 Vitamin B12 Kit, Catalog # L2KVB2, L2KVB6, kit lot 186.
Recall: Z-0537-05
·
Initiated January 24, 2005
Recall
- Recall Number
- Z-0537-05
- Event Number
- 31084
- Firm
- Diagnostic Products Corp
- FEI Number
- 3005250747
- Product Code
- CDD
- Status
- Terminated
- Root Cause
- Other
- Initiated
- January 24, 2005
- Posted
- February 11, 2005
- Terminated
- July 12, 2005
- Address
- 5210 Pacific Concourse Dr, Los Angeles, CA, 90045-6900
Description
IMMULITE 2000 Vitamin B12 Kit, Catalog # L2KVB2, L2KVB6, kit lot 186.
Reason
A low CPS limit was not incorporated in the kit barcode for IMMULITE 2000 Vitamin B12 L2KVB 2, 6 kit lot 186 only.
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.
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
Quantity
189 kits