OPTI LION Cassettes, E-Plus, Model BP7507 (25 per box), OSME TECH critical care. Intended to be used for the measurement of sodium, potassium, chloride, ionized calcium and pH in samples of whole blood, serum and plasma.
- Company
- Opti Medical Systems Inc
- Recall Initiated
- April 20, 2009
- Posted
- March 11, 2010
- Terminated
- April 17, 2012
- Recall Number
- Z-1083-2010
- Quantity
- 127 boxes of 25 cassettes each for a total of 3175 cassettes.
- Firm Location
- Roswell, GA
Reason for Recall
Outer box labeling shows an incorrect storage temperature range.
Distribution
Worldwide Distribution -- United States (CA, KY, MA and OK), Djouti (Africa), Egypt, Guatemala, India, Iraq, Pakistan, United Arab Emirates and Vietnam.
Lot / Code Info
Lot numbers: 904801, 904803 and 915800.
Root Cause
Process control
Action Taken
OPTI Medical Systems, Inc. issued a "Medical Device Correction" letter dated April 20, 2009. Consignees were instructed on how to corrected the affected product and were asked to return a completed Correction Response Card. For further information, contact OPTI Medical Systems, Inc. at +01 770 510 4444 (outside US) or 1-800-490-6784 (US).
More recalls by Opti Medical Systems Inc
Model BP7507 OPTI LION E-Plus Cassettes 25 Cassettes with Sample Probes, OPTIMedical
Cassettes are...
Oct 18, 2013
BP7561 OPTI CCA-TS B-Lac Cassette (25 per box)
Cassettes are consumables used in the OPTI CCA-TS An...
Sep 21, 2012