Device Recall ABL800 Series analyzer with FLEXQ module 의 리콜

Recall

37167

Class 2

Z-0705-2007

2007-01-16

2007-04-06

Terminated

United States

2012-05-08

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=50031

In some situations pre-registered patient data is not reset when leaving the pre-registration mode in the software. this occurs when a safe pico blood sampler associated with a specific patient is pre-registered in the analyzer by scanning a barcode.

Radiometer America issued a recall letter to their U.S. customers dated 1/16/2007. The letter informs the customers of this software anomaly and the conditions underwhich analyzer results can be stored with incorrect Patient Demographics. The letter goes on to inform the customers that a Radiometer Service Representative will be visiting each customer location shortly in order to upgrade the affected software. In the meantime, the letter recommends that the customer(s) not pre-register their samples. The letter is accompanied by an attached FAX FORM which the customer is asked to sign and complete in order to verify receipt of the recall letter and to fax back to the recalling firm.