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

FDA device recall Z-1194-2012 · posted 2012-03-08 · Terminated

Recall details

Recalling firm

Beckman Coulter Inc.

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.

Action taken

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.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

DHR

Quantity affected

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, Indi

Date initiated

2011-06-20

Date posted

2012-03-08

Date terminated

2014-09-02

Location

Brea, CA

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