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.
Enforcement
- Recall Number
- Z-0029-2014
- Event ID
- 66105
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- OPTI Medical Systems, Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Report Date
- October 30, 2013
- Initiation Date
- August 9, 2013
- Classification Date
- October 18, 2013
- Termination Date
- December 12, 2013
- Address
- 235 Hembree Park Dr, N/A, Roswell, GA, 30076-5738, United States
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.
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.
Lots 252810, 315815, 319810, 319815, 321817, 367812, 370812
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.
361 boxes of 25 cassettes each