Z-0537-05

IMMULITE 2000 Vitamin B12 Kit, Catalog # L2KVB2, L2KVB6, kit lot 186

Name: Z-0537-05 IMMULITE 2000 Vitamin B12 Kit, Catalog # L2KVB2, L2KVB6, kit lot 186
Creator: Diagnostic Products Corp
Published: 2005-01-24
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2005-01-24 / Terminated / root cause: labeling and UDI

FDA source

Diagnostic Products Corp began a recall of IMMULITE 2000 Vitamin B12 Kit, Catalog # L2KVB2, L2KVB6, kit lot 186 on 2005-01-24. The reason FDA records is "A low CPS limit was not incorporated in the kit barcode for IMMULITE 2000 Vitamin B12 L2KVB 2, 6 kit lot 186 only". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0537-05
Status: Terminated
Initiated: 2005-01-24
Posted: 2005-02-11
Terminated: 2005-07-12
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: IMMULITE 2000 Vitamin B12 Kit, Catalog # L2KVB2, L2KVB6, kit lot 186.
Product code: CDD Radioassay, Vitamin B12
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.
Root cause tag: labeling and UDI
FDA 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 in commerce: 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
Product codes and lots: IMMULITE 2000 Vitamin B12 Kit, Catalog # L2KVB2, L2KVB6, kit lot 186.

Product code CDD

K993251Class IIImmulite 2000 Vitamin B12, Model L2kvb2, L2kvb6Diagnostic Products Corp. / cleared 1999-11-17

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)