IMMULITE 2000 Vitamin B12 Kit, Catalog # L2KVB2, L2KVB6… recallZ-0537-05 · Diagnostic Products Corp · initiated Jan 24, 2005
Terminated All recalls posted in February 2005
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Diagnostic Products Corp or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
A low CPS limit was not incorporated in the kit barcode for IMMULITE 2000 Vitamin B12 L2KVB 2, 6 kit lot 186 only.
FDA root cause category: Other
What the company is doing
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.
Recall details
- Recall number
- Z-0537-05
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Jan 24, 2005
- Posted by the FDA
- Feb 11, 2005
- Recalling firm
- Diagnostic Products Corp
- Quantity
- 189 kits
- Product code
- CDD
- FDA submissions
- K993251
- 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 description
IMMULITE 2000 Vitamin B12 Kit, Catalog # L2KVB2, L2KVB6, kit lot 186.
Code information (models, lots, serial numbers)
IMMULITE 2000 Vitamin B12 Kit, Catalog # L2KVB2, L2KVB6, kit lot 186.
Other devices under the same FDA submission
1 device cleared under K993251 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- IMMULITE® 2000 Systems VB Vitamin B12 10380914Siemens Healthcare Diagnostics Products Ltd · RADIOASSAY, INTRINSIC FACTOR BLOCKING ANTIBODY1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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