Recall Z-0029-2014— OPTI Medical Systems, Inc
Class II · Terminated
Class II FDA medical device recall by OPTI Medical Systems, Inc, initiated 2013-08-09, terminated 2013-12-12. It names one FDA 510(k) clearance: K052027. 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: 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..
- Recalling firm
- OPTI Medical Systems, Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-08-09
- Terminated
- 2013-12-12
- Firm location
- Roswell, GA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.