The ABL software version 6 — Class II medical device recall Z-2162-2012
Terminated recall by Radiometer America Inc, reported 2012-08-15, distributed nationwide. A customer has reported an error on an ABL8xx configured to a Hospital Information System using the data trans
| Recall number | Z-2162-2012 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Radiometer America Inc, Westlake, OH, United States |
| Recall initiated | 2012-07-05 |
| Classified | 2012-08-08 |
| Reported by FDA | 2012-08-15 |
| Terminated | 2013-08-20 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BE, BG, BH, BO, BR, CA, CH, CL, CN, CY, CZ, DE, DK, DZ, EC, EE, EG, ES, FI, GB, GR, GT, HK, HN, HR, HU, ID, IE, IL, IN, IQ, IT, JM, JO, JP, KE, KR, KW, LB, LT, MT, MX, MY, NL, NO, NP, NZ, OM, PE, PH, PK, PL, QA, RO, RU, SA, SE, SG, SI, TH, TN, TR, TW, UA, UY, VE, VN, ZA |
Product
The ABL software version 6.12 for the ABL800 analyzer. The analyzers are intended for the in Vitro testing of: -Samples of whole blood for the parameters pH, pO2, pCO2, cK+, cNa+, cCa2+, cCl, cGlu, cLac, cCrea, ctBil, and co-oximetry parameters (ctHb, sO2, and the hemoglobin fractions FO2Hb, FCOHb, FMetHb, FHHb and FHbF) -Samples of expired air for the parameters pO2 and pCO2 -Pleura samples for the pH parameter. The ABL software version 6.12 for the ABL800 and ABL700 analyzer. The analyzers are intended for the in Vitro testing of: -Samples of whole blood for the parameters pH, pO2, pCO2, cK+, cNa+, cCa2+, cCl-, cGlu, cLac, cCrea, ctBil, and co-oximetry parameters (ctHb, sO2, and the hemoglobin fractions FO2Hb, FCOHb, FMetHb, FHHb and FHbF) -Samples of expired air for the parameters pO2 and pCO2 -Pleura samples for the pH parameter.
Reason for recall
A customer has reported an error on an ABL8xx configured to a Hospital Information System using the data transfer protocol HL7 version 2.5. If the instrument transmits results to a HIS system and the connection is broken the results are queued for later transmission. If the ABL and HIS system are configured with HL7 2.5, any results in the queue will be mixed up when the instrument transmits t
Machine access
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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.