Reported Oct 30, 2013 · Terminated
Model BP7507 OPTI LION E-Plus Cassettes 25 Cassettes with Sample Probes, OPTIMedical Cassettes are consumable used in…
OPTI Medical Systems, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: OPTI Medical Systems, Inc · 235 Hembree Park Dr · Roswell, GA · 30076-5738
Is this the product you have?
- 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.
- Lot codes and dates
Lots 252810315815319810319815321817367812370812
- Amount recalled
- 361 boxes of 25 cassettes each
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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