Z-0029-2014Class II

Model BP7507 OPTI LION E-Plus Cassettes 25 Cassettes with Sample Probes, OPTIMedical Cassettes are consumable...

Name: Z-0029-2014 Model BP7507 OPTI LION E-Plus Cassettes 25 Cassettes with Sample Probes, OPTIMedical Cassettes are consumable...
Creator: OPTI Medical Systems, Inc
Published: 2013-08-09
License: https://open.fda.gov/license/

Opti Medical Systems Inc / initiated 2013-08-09 / Terminated / root cause: labeling and UDI

FDA source

OPTI Medical Systems, Inc began a recall of Model BP7507 OPTI LION E-Plus Cassettes 25 Cassettes with Sample Probes, OPTIMedical Cassettes are consumable used in the OPTI LION Electrolyte Analyzer... on 2013-08-09. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0029-2014
Classification: Class II
Status: Terminated
Initiated: 2013-08-09
Posted: 2013-10-18
Terminated: 2013-12-12
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.
Product code: JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
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.
Root cause tag: labeling and UDI
FDA 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 [email protected] 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: [email protected] Please contact OPTI Medical Systems, Technical Support department at 1-800-490-6784 if you have questions related to this notice.
Quantity in commerce: 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.
Product codes and lots: Lots 252810, 315815, 319810, 319815, 321817, 367812, 370812

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0029-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0029-2014	Class II	Terminated	Voluntary: Firm initiated	2013-10-30	2013-10-18

Product code JJE

K052027Class IIOpti Lion Electrolyte Analyzer, Model Gd7200Osmetech, Inc. / cleared 2005-09-29

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)