Z-2115-2025Class II

Access Vitamin B12 Reagent, Catalog Number 33000, Lot Number 439850

Name: Z-2115-2025 Access Vitamin B12 Reagent, Catalog Number 33000, Lot Number 439850
Creator: Beckman Coulter, Inc.
Published: 2025-02-27
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2025-02-27 / Completed / root cause: manufacturing process

FDA source

Beckman Coulter, Inc. began a recall of Access Vitamin B12 Reagent, Catalog Number 33000, Lot Number 439850 on 2025-02-27. FDA classified it as Class II and gives the reason as "Beckman Coulter has received complaints of erroneous Vitamin B12 results when using Access Vitamin B12 Reagent lot 439850. The affected reagent lot may cause erroneously low or high Vitamin B12 results, leading to a...". As of 2026-09-10, the recall status on record is Completed, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2115-2025
Classification: Class II
Status: Completed
Initiated: 2025-02-27
Posted: 2025-07-11
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Access Vitamin B12 Reagent, Catalog Number 33000, Lot Number 439850
Product code: CDD Radioassay, Vitamin B12
Reason for recall: Beckman Coulter has received complaints of erroneous Vitamin B12 results when using Access Vitamin B12 Reagent lot 439850. The affected reagent lot may cause erroneously low or high Vitamin B12 results, leading to a delayed or improper diagnosis and/or repeat testing.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: An URGENT MEDICAL DEVICE RECALL notification letter dated 2/19/25 was sent to customers. ACTION: Discontinue using Access Vitamin B12 reagent lot 439850. Discard all remaining reagent packs from this lot following your laboratory procedures. Beckman Coulter recommends sharing the content of this letter with your laboratory and/or medical director regarding the need to review previous patient results. Contact your local Beckman Coulter representative for replacement product requests. Please share this information with your laboratory staff and retain this notification as part of your laboratory Quality System documentation. If you have forwarded any of the affected product listed above to another laboratory, please provide them a copy of this letter. So that we are assured you have received this important communication, please respond within 10 days in one of the following ways: Electronically, if you received this communication via email. Manually, complete and return the enclosed Response Form. If you have any questions regarding this notice, please contact our Customer Support Center: From our website: http://www.beckmancoulter.com You may request replacement product by contacting your local Beckman Coulter Representative for replacement.
Quantity in commerce: 10,000 units
Distribution: International distribution to the country of Andorra, Bulgaria, Denmark, Estonia, France, Germany, Greece, Ireland, Italy, Maldives, Netherlands, Portugal, Romania, Spain, Switzerland, Turkey, United Kingdom of Great Britain and Northern Ireland
Product codes and lots: UDI-DI: 15099590224301; Lot Number: 439850

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2115-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2115-2025	Class II	Completed	Voluntary: Firm initiated	2025-07-23	2025-07-11

Product code CDD

K955436Class IIAccess Vitamin B12 Assay (Modification)Bio-Rad Laboratories, Inc. / cleared 1996-01-24

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)