FDA Device recall Z-2163-2012
The ABL software version 6.12 for the ABL800 and ABL700 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 and ABL700 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-2163-2012 |
| 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 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. 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 | ABL725: 441R0086N008, 441R0292N010, and 441R0520N009U ABL 735: 441R0050N001, 441R0231N0009, 441R0234N0010, 441R0292N0…ABL725: 441R0086N008, 441R0292N010, and 441R0520N009U ABL 735: 441R0050N001, 441R0231N0009, 441R0234N0010, 441R0292N0009, 441R0303N010, 441R0340N004, 441R0343N010, and 441R0522N008 |
|---|
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-2163-2012%22
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