Z-2124-2017Class II

Microalbumin Reagent, Catalog No. 475100, Product Labeling A18520AL MA reagent, when used in conjunction with...

Name: Z-2124-2017 Microalbumin Reagent, Catalog No. 475100, Product Labeling A18520AL MA reagent, when used in conjunction with...
Creator: Beckman Coulter Inc.
Published: 2017-04-24
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2017-04-24 / Terminated

FDA source

Beckman Coulter Inc. began a recall of Microalbumin Reagent, Catalog No. 475100, Product Labeling A18520AL MA reagent, when used in conjunction with UniCel DxC 600/800 System(s) and SYNCHRON Systems... on 2017-04-24. FDA classified it as Class II and gives the reason as "Beckman Coulter has confirmed that MA Reagent Lot M609458 may recover outside the lower limit of the published insert range for Beckman Coulter Urine Protein Control Level 1". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2124-2017
Classification: Class II
Status: Terminated
Initiated: 2017-04-24
Posted: 2017-05-22
Terminated: 2017-12-30
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: Microalbumin Reagent, Catalog No. 475100, Product Labeling A18520AL MA reagent, when used in conjunction with UniCel DxC 600/800 System(s) and SYNCHRON Systems MA Calibrator, is intended for quantitative determination of Albumin concentration in human urine
Product code: DCF Albumin, Antigen, Antiserum, Control
Reason for recall: Beckman Coulter has confirmed that MA Reagent Lot M609458 may recover outside the lower limit of the published insert range for Beckman Coulter Urine Protein Control Level 1.
FDA root cause: Under Investigation by firm
Action: Beckman Coulter sent an Urgent Medical Device Recall letter dated April 24, 2017, to affected customers to inform them that Beckman Coulter has confirmed that MA Reagent Lot M609458 may recover outside the lower limit of the published insert range for Beckman Coulter Urine Protein Control Level 1. Internal testing has confirmed that MA is recovering within the published insert range for Beckman Coulter Urine Protein Control Level 2. Customers are informed of the impact, actions to be taken, and resolution. Customers are instructed to complete and return the enclosed response form within 10 days. Customers with questions are instructed to Customer Support Center via http://www.beckmancoulter.com/customersupport/support, call 1-800-854-3633 in the United States and Canada, and outside US and Canada they are instructed to contact their local Beckman Coulter Representative.
Quantity in commerce: 3,158 units total (1,957 units in US)
Distribution: Worldwide Distribution - US (nationwide) and Internationally to Australia, Belgium, Brunei, Bulgaria, Canada, China, Colombia, Czech Republic, France, Germany, Guatemala, India, Italy, Japan, Mayotte, Mexico, Netherlands, Oman, Philippines, Portugal, Qatar, Saudi Arabia, South Africa, Spain, Switzerland, Taiwan, and United Kingdom.
Product codes and lots: M609458

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2124-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2124-2017	Class II	Terminated	Voluntary: Firm initiated	2017-05-31	2017-05-22

Product code DCF

K082251Class IISynchron Systems Microalbumin (Ma) Reagent, Model 475100Beckman Coulter, Inc. / cleared 2009-04-08

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)