Synchron Systems Rheumatoid Factor (RF) Reagent, Synchron CX Systems RF Calibrator

• • Terminated Z-1194-2012 FDA Unclassified (pre-2012) ·initiated 20 Jun 2011

  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.

• • Terminated Z-1743-2011 FDA Unclassified (pre-2012) ·initiated 21 Jun 2010

  The recall was initiated because Beckman Coulter testing indicated that Rheumatoid Factor (RF) reagent lot M907325 will not remain stable to the labeled expiration date.

510(k) Number

K971788 ↗

FDA Product Code

DHR

Device Class

Class II

Regulation

21 CFR Part 866.5775

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

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See all devices from Beckman Instruments, Inc. →

• What is the Synchron Systems RF Reagent and CX Calibrator used for?

  This device is used for the detection of rheumatoid factor in clinical laboratory settings. The reagent and calibrator work together to calibrate rheumatoid factor testing on Synchron CX Systems, enabling accurate in vitro diagnostic measurement of RF levels in patient samples.

• How is the Synchron Systems RF Reagent and CX Calibrator supplied?

  The device is supplied as an in vitro diagnostic product consisting of the Synchron Systems Rheumatoid Factor (RF) Reagent and the Synchron CX Systems RF Calibrator, which is a six-level calibrator set. It is intended for use together on Synchron CX Systems for RF testing calibration.

• Is the Synchron Systems RF Reagent and CX Calibrator sterile or single-use?

  The device data does not specify sterility or single-use status for this reagent and calibrator system. As an in vitro diagnostic reagent and calibrator intended for laboratory use, it is designed for multiple uses within its stability period when handled according to manufacturer instructions, but reuse specifics are not detailed in the provided information.

• What regulatory pathway was used for the Synchron Systems RF Reagent and CX Calibrator?

  The device received FDA 510(k) clearance, as indicated in the AUTHORIZATIONS field. It was found substantially equivalent to a predicate device under product code DHR and regulation number 866.5775, with a traditional clearance type granted on June 3, 1997.