OPTI Medical Systems, Inc: Medical Device Recall in 2013 - (Recall #: Z-0029-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: August 9, 2013

Date Posted: October 30, 2013

Recall Number: Z-0029-2014

Event ID: 66105

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.

Status: Terminated

Product Quantity: 361 boxes of 25 cassettes each

Code Information:

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

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.

Voluntary or Mandated:

Voluntary: Firm initiated