BP7561 OPTI CCA-TS B-Lac Cassette (25 per box) Cassettes are consumables used in the OPTI CCA-TS Analyzer intended to be
FDA device recall Z-2440-2012 · posted 2012-09-21 · Terminated
Recall details
- Recalling firm
- OPTI Medical Systems, Inc
- Reason for recall
- The values reported for PCO2 by BP7561 B-Lac cassettes are biased at high concentrations when used at altitudes above 2800 feet (853 meters).
- Action taken
- OPTI Medical sent a Urgent Field Correction Notice dated July 3, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to apply correlation factors to correct the PCO2 measurement reported by the device. They were instructed to determine the elevation (altitude above sea level) for their location and to use the tables provided in the recall notification to determine the correct correlation factor. A website was provided if the consignee did not know their elevation. Steps were provided to enter the correlation factor into their OPTI CCA TS analyzer. Please contact OPTI Medical Technical Support at 1-770-510-4444 or 1-800-490-6784.
- Root cause
- Process design
- Status
- Terminated
- Product code
- CHL
- Quantity affected
- 895 boxes (25 cassettes per box)
- Distribution
- Worldwide Distribution -- US (nationwide) including the states of AZ, ID, TX and UT., and the countries of Argentina, Bolivia, China, Ecuador, France, Germany Greece, India, Indonesia, Iran, Ireland,
- Date initiated
- 2012-07-03
- Date posted
- 2012-09-21
- Date terminated
- 2013-04-11
- Location
- Roswell, GA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| OPTI CCA-TS, B-LAC CASSETTE MODEL BP7561 (K093280) | Opti Medical Systems, Inc. | 2011-01-07 |