Cell-Dyn 3500 System with Immature Reticulocyte Fraction (Irf), Cell-Dyn 3700 System with Immature Reticulocyte Fraction

510(k) K991605

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

9 closed

Documents

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK991605	Date9 Jul 1999Cleared	StatusActive

9 recalls · FDA

4 recalls, same reason
- Terminated Z-2016-2011 FDA Unclassified (pre-2012) initiated 15 Mar 2011
- Terminated Z-2015-2011 FDA Unclassified (pre-2012) initiated 15 Mar 2011
- Terminated Z-2014-2011 FDA Unclassified (pre-2012) initiated 15 Mar 2011
- Terminated Z-2020-2011 FDA Unclassified (pre-2012) initiated 15 Mar 2011
The Nylon Washer has an outer diameter which is undersized resulting in the inability to generate patient results.
- Terminated Z-2351-2010 FDA Unclassified (pre-2012) initiated 16 Apr 2010
Epoxy holding the two parts of the waste reservoir together fails, potentially resulting in biohazardous fluid leaks.
2 recalls, same reason
- Terminated Z-1703-2011 FDA Unclassified (pre-2012) initiated 27 Mar 2009
- Terminated Z-1701-2011 FDA Unclassified (pre-2012) initiated 27 Mar 2009
FIRE HAZARD-- Some power supply modules may have incorrect fuses installed, which may result in fires and smoking.
2 recalls, same reason
- Terminated Z-1200-2007 FDA Unclassified (pre-2012) initiated 11 May 2007
- Terminated Z-1199-2007 FDA Unclassified (pre-2012) initiated 11 May 2007
The product failed electrostatic discharge testing, which could result in product failure.

1 jurisdiction

United States — FDA 510(k) Active

510(k)