Radiometer ABL Software Recall for HL7 Data Transmission Errors
Radiometer America Inc. is recalling ABL software version 6.12 for ABL800 and ABL700 analyzers because HL7 2.5 data transmission errors can mix up queued results.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves data integrity errors (mixed up results) rather than direct physical injury or contamination, fitting the criteria for moderate severity involving potential adverse health consequences due to incorrect data.
Plain-English summary
Radiometer America Inc. is recalling ABL software version 6.12 for the ABL800 and ABL700 analyzers. The recall involves 6,854 ABL 7xx units distributed worldwide, including the United States and numerous international countries. The analyzers are intended for in vitro testing of whole blood, expired air, and pleura samples for various parameters such as pH, pO2, and pCO2.
The recall was initiated after a customer reported an error on an ABL8xx instrument configured to a Hospital Information System (HIS) using the HL7 version 2.5 data transfer protocol. If the connection between the instrument and the HIS system is broken, results are queued for later transmission. When the ABL and HIS system are configured with HL7 2.5, any results in the queue may be mixed up when the instrument transmits them.
Healthcare facilities using these analyzers with HL7 2.5 configurations should contact Radiometer America Inc. for further instructions on correcting the software issue to ensure accurate data transmission.
The recalled product
- 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
- Manufacturer
- Radiometer America Inc
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (10)
- ABL725: 441R0086N008
- 441R0292N010
- and 441R0520N009U ABL 735: 441R0050N001
- 441R0231N0009
- 441R0234N0010
- 441R0292N0009
- 441R0303N010
- 441R0340N004
- 441R0343N010
- and 441R0522N008
Distribution
Part of a larger recall action
This product is one of 3 recalled by Radiometer America Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
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