FDA Device recall Z-2162-2012
The ABL software version 6.12 for the ABL800 analyzer
- FDA Device
- Class II
- terminated
- Published 2012-08-15
On 2012-08-15 the FDA classified a Class II recall of The ABL software version 6.12 for the ABL800 analyzer by Radiometer America, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2162-2012 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-07-05 |
| Published | 2012-08-15 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Radiometer America |
| Distribution | US |
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
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
Identifiers
| code_info | ABL800 BASIC: 754R0406N012U ABL800 BASIC with AutoCheck: 754R0742N006 754R0467N002 754R0466N008 754R0467N001 7…ABL800 BASIC: 754R0406N012U ABL800 BASIC with AutoCheck: 754R0742N006 754R0467N002 754R0466N008 754R0467N001 754R0433N011 754R0434N001 754R0437N005 754R0437N006 754R0437N007 754R0436N004 754R0437N001 754R0436N003 754R0436N005 754R0436N006 754R0437N003 754R0437N002 754R0432N003 754R0432N004 754R0432N005 754R0436N002 754R0467N003 754R0276N001 754R1306N002 754R1306N003 754R1308N003 754R1308N005 754R1308N006 754R1309N001 754R1309N005 754R1309N006 754R1309N007 754R1310N001 754R1310N002 754R1310N003 754R1310N004 754R1310N005 754R1310N006 754R1310N007 754R1311N001 754R1311N002 754R1311N003 754R1311N004 754R1311N006 754R1312N001 754R1312N003 754R1312N005 754R0294N008 754R1191N002 754R1191N003 754R1191N004 754R1191N005 754R0400N010 754R0401N001 754R0400N004 754R0400N005 754R0387N012 754R0886N003 754R0886N004 754R0306N001 754R0306N002 754r1098n004 754r1098n006 754R1080N004 754R1080N006 754R1233N004 754R1233N006 754R1211N004 |
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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-2162-2012%22
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