Model BP7507 OPTI LION E-Plus Cassettes 25 Cassettes with Sample… — Class II medical device recall Z-0029-2014
Terminated recall by OPTI Medical Systems, Inc, reported 2013-10-30, distributed nationwide. OPTI LION E-Plus Cassettes were labeled with an incorrect barcode. The incorrect barcode could perfect the per
| Recall number | Z-0029-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | OPTI Medical Systems, Inc, Roswell, GA, United States |
| Recall initiated | 2013-08-09 |
| Classified | 2013-10-18 |
| Reported by FDA | 2013-10-30 |
| Terminated | 2013-12-12 |
| Distributed | Nationwide (US) |
| Countries outside the US | CN, GT, IN, IQ, KR |
| Reason classes | labeling |
| Lot numbers | 252810, 315815, 319810, 319815, 321817, 367812, 370812 |
| Model numbers | BP7507 |
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0029-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.