OPTI LION E-Plus Cassette, Model BP7507, Opti Medical (25 Cassettes with Samples Probes per box). Cassettes are consumab

FDA device recall Z-2558-2011 · posted 2011-06-14 · Terminated

Recall details

Recalling firm

OPTI Medical Systems, Inc

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.

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.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

CGZ

Quantity affected

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.

Date initiated

2011-03-15

Date posted

2011-06-14

Date terminated

2011-08-08

Location

Roswell, GA

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