Reported Oct 3, 2012 · Terminated
BP7561 OPTI CCA-TS B-Lac Cassette (25 per box) Cassettes are consumables used in the OPTI CCA-TS Analyzer intended to…
OPTI Medical Systems, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: OPTI Medical Systems, Inc · 235 Hembree Park Dr · Roswell, GA · 30076-5738
Is this the product you have?
- BP7561 OPTI CCA-TS B-Lac Cassette (25 per box) Cassettes are consumables used in the OPTI CCA-TS Analyzer intended to be used for in vitro measurements of pH, PCOX2 PO2, lactate (lactic acid), total hemoglobin (tHb), and oxygen saturation (SO2), in heparinized whole blood samples (either arterial or venous) on the OPTI CCA-TS system, in either a clinical setting or point of care locations. Cassettes contain one-time use sensors that are used with the OPTI CCA-TS analyzer to perform in-vitro measurements of blood gases and metabolites. OPTI CCA-TS B-Lac Cassettes are supplied in boxes of 25 and may only used with the OPTI CCA-TS Analyzer.
- Lot codes and dates
- Lot numbers
110650114650114651114652114653116650116652117650118651121650121651122652122652122653122654122655122656122657123654123655124650133650134651136650146650149650202650208650208651209560209651211650212651213650214650215650215651221650222650 and 224650
- Lot numbers
- Amount recalled
- 895 boxes (25 cassettes per box)
Where it was sold
Why it was recalled
The values reported for PCO2 by BP7561 B-Lac cassettes are biased at high concentrations when used at altitudes above 2800 feet (853 meters).
This product could cause temporary or reversible health problems — stop using it.
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