Radiometer ABL90 FLEX Software Recall for HL7 Data Transmission Errors
Radiometer America Inc. is recalling ABL90 FLEX software version 2.7 MR3 because a data transfer error can cause mixed-up results when transmitting to hospital systems.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device where a software error can lead to mixed-up test results, posing a risk of harm to patients through incorrect clinical decisions, although no specific injuries or illnesses are reported in the source text.
Plain-English summary
Radiometer America Inc. is recalling ABL90 FLEX software version 2.7 MR3. The ABL90 FLEX analyzer is intended for in vitro testing of samples of heparinized whole blood. The recall affects 1,427 ABL 90 instruments with Part Number 393-090, covering production runs 393-090R0026N0010 to 393-090R0179N010.
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 is broken, results are queued for later transmission. When the instrument is configured with HL7 2.5, any results in the queue may be mixed up during transmission.
The affected products were distributed worldwide, including the United States, Canada, and numerous other countries. Users should contact Radiometer America Inc. for further instructions regarding the software update or replacement.
The recalled product
- Product
- ABL90 FLEX software version 2.7 MR3. The ABL90 FLEX analyzer is intended for in vitro testing of samples of heparinized whole blood.
- Manufacturer
- Radiometer America Inc
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 (3)
- Part Number: 393-090
- all production runs
- 393-090R0026N0010 to 393-090R0179N010
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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Similar recalls
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