BP7561 OPTI CCA-TS B-Lac Cassette — Class II medical device recall Z-2440-2012
Terminated recall by OPTI Medical Systems, Inc, reported 2012-10-03, distributed nationwide. The values reported for PCO2 by BP7561 B-Lac cassettes are biased at high concentrations when used at altitude
| Recall number | Z-2440-2012 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | OPTI Medical Systems, Inc, Roswell, GA, United States |
| Recall initiated | 2012-07-03 |
| Classified | 2012-09-21 |
| Reported by FDA | 2012-10-03 |
| Terminated | 2013-04-11 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, BO, CH, CN, DE, EC, FR, GB, GR, ID, IE, IN, IR, JP, KW, LT, LU, MA, MX, MY, NG, PL, RO, RU, SA, SG, TR, VE, VN, ZA |
| Lot numbers | 110650, 114650, 114651, 114652, 114653, 116650, 116652, 117650, 118651, 121650, 121651, 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, 224650 |
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 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).
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2440-2012. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.