FDA Device recall Z-2440-2012
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…
- FDA Device
- Class II
- terminated
- Published 2012-10-03
On 2012-10-03 the FDA classified a Class II recall of 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… by Opti Medical Systems, citing the values reported for PCO2 by BP7561 B-Lac cassettes are biased at high concentrations when used at altitudes above 2800 feet (853 meters).
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2440-2012 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-07-03 |
| Published | 2012-10-03 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Opti Medical Systems |
| Distribution | US |
Product
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.
Reason
The values reported for PCO2 by BP7561 B-Lac cassettes are biased at high concentrations when used at altitudes above 2800 feet (853 meters).
Identifiers
| code_info | Lot numbers: 110650, 114650, 114651, 114652, 114653, 116650, 116652, 117650, 118651, 121650, 121651, 122652, 122652, 12…Lot numbers: 110650, 114650, 114651, 114652, 114653, 116650, 116652, 117650, 118651, 121650, 121651, 122652, 122652, 122653, 122654, 122655, 122656, 122657, 123654, 123655, 124650, 133650, 134651, 136650, 146650, 149650, 202650, 208650, 208651, 209560, 209651, 211650, 212651, 213650, 214650, 215650, 215651, 221650, 222650 and 224650. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2440-2012%22
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