Recall Z-2558-2011
OPTI Medical Systems, Inc · initiated March 15, 2011
Product
OPTI LION E-Plus Cassette, Model BP7507, Opti Medical (25 Cassettes with Samples Probes per box). Cassettes are consumables 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. . Cassettes contain one-time use sensors that are used with the OPTI-LION analyzer to perform in-vitro measurements of electrolytes. OPTI LION E-Plus Cassettes are supplied in boxes of 25 and may only be used with the OPTI LION Electrolyte Analyzer.
Codes / lots: Lot numbers 038811 and 102812
Reason for recall
The values reported by the chloride sensors may report erroneous values below specification on aqueous controls and potentially with patient samples of whole blood and serum/plasma.
FDA-determined cause: Nonconforming Material/Component
Action taken
OPTIMedical Systems sent an "URGENT: MEDICAL DEVICE RECALL" letter dated March 15, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. Customers were notified by letter via e-mail and fax. Customers were instructed to discontinue use of the product and to return any unused product to OPTI Medical Systems, Inc. Customers outside the U.S. were instructed to destroy unused product and certify the destruction on the enclosed Recall Response Card. The Response Card was to be completed and returned to OPTI Medical Customer Service via fax. OPTI Medical Systems will replace the cassettes they have with product from another lot. Customers were instructed to contact the Technical Support Department at 1-800-490-6784 for questions relating to this notice.
Details
- Recall number
- Z-2558-2011
- Initiated
- March 15, 2011
- Posted by FDA
- June 14, 2011
- Terminated
- August 8, 2011
- Product code
- CGZ – Electrode, Ion-Specific, Chloride
- Quantity
- 86 boxes (25 units (per box)
- Distribution
- Worldwide Distribution-- USA (nationwide) including states of CA and VA, and countries of India, Lebanon, Philippines, Sweden, Venezuela and Vietnam.
- Recalling firm
- OPTI Medical Systems, Inc, Roswell, GA