Z-0029-2014 Class II Terminated
FDA device recall Z-0029-2014 was initiated by OPTI Medical Systems, Inc on August 9, 2013 and is designated Class II. 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 d… The recall status is terminated (terminated December 12, 2013). Affected quantity: 361 boxes of 25 cassettes each.
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