Recall Z-2558-2011 ยท CGZ Electrode, Ion-Specific, Chloride
OPTI Medical Systems, Inc
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 perfor
| Date | Jun 14, 2011 (initiated Mar 15, 2011) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Nonconforming Material/Component |
| Action | 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 |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K052027 | OPTI LION ELECTROLYTE ANALYZER, MODEL GD7200 Osmetech, Inc., Sep 29, 2005 |