QuikLYTE Dilution Check: used to monitor and adjust for the dilution ratio on Dimension clinical chemistry systems with

FDA device recall Z-1398-2015 · posted 2015-04-07 · Terminated

Recall details

Recalling firm

Siemens Healthcare Diagnostics, Inc.

Reason for recall

A positive bias beyond 5% resulting in a dilution check failure or an unnecessary dilution check correction if the positive bias is greater than 1% and less than 5%. The dilution check correction would be detected by QC; however, if not detected by QC, the calibration curve would be decreased and cause elevated sodium, potassium and chloride patient results.

Action taken

An Urgent Medical Device Recall letter, dated February 2015, was provided to all Dimension system customers who received the affected lot to notify them that Siemens confirmed customer complaints of failing dilution checks when using QuikLYTE Dilution Check lot 4MD707. The letter also instructed them to immediately discontinue use and discard all inventory of Dimension QuikLYTE Dilution Check lot 4MD707. Siemens offered a no charge replacement with a non-impacted lot.

Root cause

Under Investigation by firm

Status

Terminated

Product code

CEM

Quantity affected

5981

Distribution

Worldwide Distribution.

Date initiated

2015-02-24

Date posted

2015-04-07

Date terminated

2017-02-01

Location

Newark, DE

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