Z-2264-2025Class II

UIBC (Unsaturated Iron Binding Capacity), REF: OSR61205

Name: Z-2264-2025 UIBC (Unsaturated Iron Binding Capacity), REF: OSR61205
Creator: Beckman Coulter Inc.
Published: 2025-06-26
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2025-06-26 / Open, Classified / root cause: manufacturing process

FDA source

Beckman Coulter Inc. began a recall of UIBC (Unsaturated Iron Binding Capacity), REF: OSR61205 on 2025-06-26. FDA classified it as Class II and gives the reason as "Beckman Coulter identified that the Unsaturated Iron Binding Capacity (UIBC) assay is not meeting their labeled hemoglobin interference claims of no significant interference (i.e., less than 10%) up to 200 mg/dL...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2264-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-06-26
Posted: 2025-08-04
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: UIBC (Unsaturated Iron Binding Capacity), REF: OSR61205,
Product code: JMO Ferrozine (Colorimetric) Iron Binding Capacity
Reason for recall: Beckman Coulter identified that the Unsaturated Iron Binding Capacity (UIBC) assay is not meeting their labeled hemoglobin interference claims of no significant interference (i.e., less than 10%) up to 200 mg/dL hemoglobin as indicated in their instructions for use. Initial internal testing confirmed that samples with low UIBC levels failed the claimed hemolysis interference specifications with reported biases up to -43.6 % UIBC when hemolyzed serum samples contained 200 mg/dL hemoglobin.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: On July 10, 2025, Beckman Coulter issued a "Urgent Medical Device Recall" via mail and E-Mail to affected consignees. Beckman Coulter asked consignees to take the following action: 1. Sharing the content of this letter with your laboratory and/or Medical Director to evaluate the requirement for a retrospective review of UIBC results for hemolysed samples. 2. Discontinuance or disposal of this product is not necessary. 3. Per the IFU, avoid hemolysed samples when using the UIBC assay. 4. If the LIH influence check setting for hemolysis has been enabled on AU/DxC AU instruments for UIBC, update the setting per the instructions in the letter. 5. Please share this information with your laboratory staff and retain this notification as part of your laboratory Quality System documentation. 6. If you have forwarded any of the affected product listed above to another laboratory, please provide them a copy of this letter. 7. 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 or manually, complete and return the enclosed Response Form.
Quantity in commerce: 56,696 units
Distribution: US: AK, AL, AR, CO, CT, DC, DE, ID, UT OUS: Algeria, Argentina, Australia, Bahrain, Bangladesh, Belarus, Belgium, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, China, Colombia, Costa Rica, Croatia, Czechia, Egypt, El Salvador, Ethiopia, Georgia, Germany, Ghana, Gibraltar, Greece, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Jordan, Kazakhstan, Korea, Republic of, Kuwait, Lebanon, Libya, Lithuania, Malaysia, Maldives, Mexico, Morocco, Mozambique, Myanmar, Nepal, Netherlands, Nigeria, North Macedonia, Oman, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Somalia, South Africa, Spain, Sri Lanka, Sweden, Taiwan, Province of China, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom of Great Britain and Northern Ireland, Uzbekistan, Viet Nam, Yemen.
Product codes and lots: All Lots/(01)15099590011925

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2264-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2264-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-08-13	2025-08-04

Product code JMO

K041793Class IOlympus Unsaturated Iron Binding Capcity Reagent, Osr6124/0sr6524Olympus America, Inc. / cleared 2004-07-16

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)