Z-1194-2012

SYNCHRON Rheumatoid Factor (RF) Reagent, Part Number: 475136 A rheumatoid factor immunological test system is...

Name: Z-1194-2012 SYNCHRON Rheumatoid Factor (RF) Reagent, Part Number: 475136 A rheumatoid factor immunological test system is...
Creator: Beckman Coulter Inc.
Published: 2011-06-20
License: https://open.fda.gov/license/

Siemens Healthcare Diagnostics Inc. / initiated 2011-06-20 / Terminated / root cause: manufacturing process

FDA source

Beckman Coulter Inc. began a recall of SYNCHRON Rheumatoid Factor (RF) Reagent, Part Number: 475136 A rheumatoid factor immunological test system is a device that consists of the reagents used to... on 2011-06-20. The reason FDA records is "The recall was initiated because Beckman has confirmed that the all in date lots of Synchron Rheumatoid Factor (RF) Reagent might generate false positive results or calibration failures". 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-1194-2012
Status: Terminated
Initiated: 2011-06-20
Posted: 2012-03-08
Terminated: 2014-09-02
Recalling firm: Siemens Healthcare Diagnostics Inc.
Product: SYNCHRON Rheumatoid Factor (RF) Reagent, Part Number: 475136 A rheumatoid factor immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the rheumatoid factor (antibodies to immunoglobulins) in serum, other body fluids, and tissues.
Product code: DHR System, Test, Rheumatoid Factor
Reason for recall: The recall was initiated because Beckman has confirmed that the all in date lots of Synchron Rheumatoid Factor (RF) Reagent might generate false positive results or calibration failures.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Beckman Coulter sent an Urgent Field Safety Notice/Product Correction letter dated June 20, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were notified that Beckman Coulter is developing a new RF assay. In the meantime due to current issues related to shelf life and low end sensitivity, Beckman has decided to take the product off the market effective immediately. Beckman will keep the customers updated on their progress and advise when the new assay becomes available. Customers were instructed to complete and return the enclosed Response Form with in 10 days. Customers with questions regarding this notice can contact their local Beckman Sales representative or contact Customer Support Center at www.BeckmanCoulter.com/CustomerSupport/Support or call (800) 854-3633 in the US and Canada.
Quantity in commerce: 22,081 units total (12,462 units in US)
Distribution: Worldwide Distribution - USA (nationwide) and worldwide to foreign countries: Australia, Belgium, China, Costa Rica, Czech Republic, Finland, France, French Polynesia, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Lithuania, Macao, Mexico, Netherlands, New Zealand, Poland, Russian Federation, Serbia, Slovakia, South Africa, Spain, Switzerland, Taiwan, Turkey, United Arab Emirates, and the United Kingdom.
Product codes and lots: All in-date lots

Product code DHR

K971788Class IISynchron Systems Rheumatoid Factor (RF) Reagent, Synchron Cx Systems RF CalibratorBeckman Instruments, Inc. / cleared 1997-06-03

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)