Z-3028-2020Class II

UIBC; Catalog Number: OSR61205; UDI (01) 15099590011925; IVD; Rx Only; WARNING H316 H317 H351 H373 H411 -

Name: Z-3028-2020 UIBC; Catalog Number: OSR61205; UDI (01) 15099590011925; IVD; Rx Only; WARNING H316 H317 H351 H373 H411 -
Creator: Beckman Coulter Inc.
Published: 2020-08-18
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2020-08-18 / Terminated / root cause: manufacturing process

FDA source

Beckman Coulter Inc. began a recall of UIBC; Catalog Number: OSR61205; UDI (01) 15099590011925; IVD; Rx Only; WARNING H316 H317 H351 H373 H411 - Product Usage: System reagent for the quantitative... on 2020-08-18. FDA classified it as Class II and gives the reason as "The manufacturer has identified that the use of Unsaturated Iron Binding Capacity (UBIC) lot 2690 will produce erroneously high patient results at the low end of the linear range". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-3028-2020
Classification: Class II
Status: Terminated
Initiated: 2020-08-18
Posted: 2020-09-30
Terminated: 2021-09-08
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: UIBC; Catalog Number: OSR61205; UDI (01) 15099590011925; IVD; Rx Only; WARNING H316 H317 H351 H373 H411 - Product Usage: System reagent for the quantitative determination of Unsaturated Iron Binding Capacity (UIBC) in human serum and plasma on Beckman Coulter AU analyzers.
Product code: JMO Ferrozine (Colorimetric) Iron Binding Capacity
Reason for recall: The manufacturer has identified that the use of Unsaturated Iron Binding Capacity (UBIC) lot 2690 will produce erroneously high patient results at the low end of the linear range.
Root cause tag: manufacturing process
FDA root cause: Under Investigation by firm
Action: An Urgent Medical Device Recall letter was sent on 08/18/2020 to the affected customers via mail and/or email. The customers are advised to discontinue the use of UIBC lot 2690. When available, replace it with an unaffected lot of UIBC.
Quantity in commerce: 219 units
Distribution: Worldwide distribution - US Nationwide distribution including in the states of CA, FL and NJ. The countries of Algeria, Egypt, Philippines and Taiwan.
Product codes and lots: LOT 2690; Expiration date 10/01/2021

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3028-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3028-2020	Class II	Terminated	Voluntary: Firm initiated	2020-10-07	2020-09-30

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)