FDA Medical Device Recalls (openFDA)
OPTI Medical Systems, Inc: 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.
- Recall number
- Z-0029-2014
- Recalling firm
- OPTI Medical Systems, Inc
- Product
- 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.
- Status
- Terminated
- Initiated
- 2013-08-09
- Posted
- 2013-10-18
- Terminated
- 2013-12-12
- Reason
- 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.
- Root cause
- Error in labeling
- Action
- The firm, OPTIMedical, sent an "URGENT: MEDICAL DEVICE RECALL" letter dated August 9, 2013 via email and fax to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately discontinue use of the product; return any unused product to OPTI Medical System; distributors outside the U.S. may destroy unused product and certify the instructions on the enclosed Recall Response Card; contact your distributor or OPTI Medical System Technical Support at 1-800-490-6784 or technicalsupport@optimedical.com to obtain authorization number and shipping instructions; and complete and return the Recall Response Card to technical support via fax to 1-770-510-4447; mail to: OPTI Medical Technical Support, OPTI Medical Systems, Inc., 235 Hembree Park Drive, Roswell, GA 30076 or email: technicalsupport@optimedical.com Please contact OPTI Medical Systems, Technical Support department at 1-800-490-6784 if you have questions related to this notice.
- Quantity
- 361 boxes of 25 cassettes each
- Distribution
- 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.
- Lot, serial or model codes
- Lots 252810, 315815, 319810, 319815, 321817, 367812, 370812
- 510(k) numbers
- ["K052027"]
- PMA numbers
- not on file
- Product code
- JJE
- Firm FEI
- 3004102403
- Firm city
- Roswell
- Firm state
- GA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28