Siemens Chek-Stix Positive and Negative Control Strips for Urine Chemistry (Distributed OUS Only) Catalog Number: 1360L

FDA device recall Z-0638-2013 · posted 2013-01-04 · Terminated

Recall details

Recalling firm

Siemens Healthcare Diagnostics Inc

Reason for recall

When these lots of control material are reconstituted, the positive control solution leukocyte result may become negative if the solution is held for more than two hours above 25C (77F).

Action taken

Siemens issued An Urgent Field Safety Notice via e-mail to all affected SiemensHealthcare Diagnostics Regional offices on November 21, 2012 both in the United States and foreign accounts. This notice informed customers of the issue with the CLINITEK Atlas and Chek-Stix Positive Urinalysis Control Solutions When these lots of control material are reconstituted, the positive control solution leukocyte result may become negative if the solution is held for more than two hours above 25C (77F). You can use the reconstituted positive control solution for up to eight hours if the solution is held at 25C (77F) or lower. If the operating temperature is greater than 25C and lower than 30C (77F and 86F), the solution can be used for up to two hours. For questions regarding this recall call 781-269-3158.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

JJW

Quantity affected

700

Distribution

Worldwide Distribution - USA (nationwide) and internationally to Canada, Aruba, Brazil, Denmark, India, Mexico, New Zealand, Singapore,Thailand, Bahamas, South Wales, and Hong Kong,

Date initiated

2012-11-21

Date posted

2013-01-04

Date terminated

2014-11-06

Location

Norwood, MA

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