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

Recall Z-1462-2017 — ABL90 Flex Model #: 393-090 Portable, automated analyzer that measures pH, blood gases, electrolytes, glucose, lactate, bilirubin, and oximetry in whole blood.

U.S. FDA — Device Enforcement · United States · 2017-01-26 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1462-2017
Date of alert: 2017-01-26
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Radiometer America Inc
Product category: device
Product type: Devices

Reported risk: Reports that the sample type "cord blood" has been changed into the two sample types "cord blood arterial" and "cord blood venous.

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

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Recall Z-1462-2017 — ABL90 Flex Model #: 393-090 Portable, automated analyzer that measures pH, blood gases, electrolytes, glucose, lactate, bilirubin, and oximetry in whole blood.

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