FDA Devices recall · Reported October 30, 2013
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 Custom…
Opti Medical Systems, Inc recalled Model BP7507 OPTI LION E-Plus Cassettes 25 Cassettes with Sample Probes, OPTIMedical C… - a moderate-severity action.
Model BP7507 OPTI LION E-Plus Cassettes 25 Cassettes with Sample Probes, OPTIMedical C… was recalled by Opti Medical Systems, Inc in October 30, 2013. Reason: OPTI LION E-Plus Cassettes were labeled with an incorrect barcode. The incorrect barcode could perfect the pe…. Check the official notice for the remedy. Verify recall #Z-0029-2014 with the FDA Devices before acting.
The recall
Opti Medical Systems, Inc issued this moderate-severity FDA Devices recall-OPTI LION E-Plus Cassettes were labeled with an incorrect barcode. The incorrect barcode could perfect the pe….
- Moderate
- severity level
- Class II
- classification
- October 30, 2013
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0029-2014 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 41,021 medical devices recalls on record
Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0029-2014 |
| Date reported | October 30, 2013 |
| Date initiated | August 9, 2013 |
| Recalling firm | Opti Medical Systems, Inc |
| Firm location | Roswell, GA |
| Affected scope | 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. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0029-2014) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Nationwide recalls with similar severity or category timing
Drug and device notices outside this firm and state, matched by severity timing and product category.
Similar severity · nearest report date
Same archive severity grade (Moderate), closest by report date among other firms and states.
Similar Medical Devices · nearest report date
Same product category, closest by report date among other firms and states (deduped against the severity set).
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Methodology · Corrections · Archive as of August 2026