Siemens Dimension Vista CHEM 1 CAL 의 리콜

Recall

69063

Class 2

Z-2720-2014

2014-08-18

2014-09-30

Terminated

United States

2015-02-02

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=129484

Siemens healthcare diagnostics has received complaints for low recovery of magnesium (mg) quality control (qc) and patient samples following calibration of mg with the dimension vista® chem 1 cal, lot 3gm081. investigation by siemens confirms that qc and patient samples under-recovers mg by 0.25 mg/dl [0.10 mmol/l] across the assay range following calibration with 3gm081.

Siemens sent an Urgent Medical Device Dorrection letter, dated August 2014, to all affected consignees. The letter identified the product, the problem, and the actions to be taken. Consignees were instructed if they still have an active calibration of MG with this lot of CHEM 1 CAL, they should immediately calibrate MG with an alternate lot of CHEM 1 CAL. Consigness were instructed to retain the letter with their laboratory records, and to forward the letter to those who may have received the affected product. Customers with questions were instructed to contact their Siemens Customer Care Center - Techhnical Solutions or their local Siemens technical support representative.