Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2164-2012 — ABL90 FLEX software version 2.7 MR3. The ABL90 FLEX analyzer is intended for in vitro testing of samples of heparinized whole blood.

U.S. FDA — Device Enforcement · United States · 2012-07-05 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2164-2012
Date of alert: 2012-07-05
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Radiometer America Inc
Product category: device
Product type: Devices

Reported risk: 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

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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Recall Z-2164-2012 — ABL90 FLEX software version 2.7 MR3. The ABL90 FLEX analyzer is intended for in vitro testing of samples of heparinized whole blood.

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