Home / Recalls / OPTI Medical Systems, Inc / Z-0029-2014

Z-0029-2014 Class II Terminated

Recalled by OPTI Medical Systems, Inc — Roswell, GA

Recall Details

Product Type: Devices
Report Date: October 30, 2013
Initiation Date: August 9, 2013
Termination Date: December 12, 2013
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 361 boxes of 25 cassettes each

Product Description

Model BP7507 OPTI LION E-Plus Cassettes 25 Cassettes with Sample Probes, OPTIMedical Cassettes are consumable used in the OPTI LION Electrolyte Analyzer intended to be used for the measurement of sodium, potassium, chloride, ionized calcium and pH in samples of whole blood, serum, and plasma.

Reason for Recall

OPTI LION E-Plus Cassettes were labeled with an incorrect barcode. The incorrect barcode could perfect the performance of one or more parameters as the product ages. Also a Customer complaint from a distributor reported that a customer was getting QC failures.

Distribution Pattern

Worldwide distribution: US (nationwide) including states of: CA, MA, MN, and VA; and countries of: China, Guatemala, India, Iraq, South Korea, and Untied Arab Emirates.

Code Information

Lots 252810, 315815, 319810, 319815, 321817, 367812, 370812