syngo(R) Lab Data Manager and syngo(R) Lab Process Manager recalled

Timeline

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

When using the syngo Quality Control package the system may not perform as intended for Multi-Rule QC violation [e.g., 2(2S), 4(1s) and 10x], unless configured using the instructions on page 2 of the recall notification. QC status may not be flagged appropriately. If auto-verification rules are defined to hold patient results when QC status is out, the patient results will not be held as expecte

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

syngo(R) Lab Data Manager and syngo(R) Lab Process Manager, all versions. This device is classified as a data calculator and processing module for use with In-vitro diagnostic devices. It also provides work flow management as well as remote instrument control to multiple interfaced instruments.

Where it was distributed

USA ( nationwide ) including the states of AZ, CA, FL, IL, KY, MD, MA, MN, MS, MO, NE, NH, NJ, NY, NC, OH, PA, TX, VA and WV.

Nationwide ArizonaCaliforniaFloridaIllinoisKentuckyMassachusettsMarylandMinnesotaMissouriMississippiNorth CarolinaNebraskaNew HampshireNew JerseyNew YorkOhioPennsylvaniaTexasVirginiaWest Virginia