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

Recall Z-2493-2020 — Blood gases (PCO2, PO2) and blood pH test system; ABL800 FLEX; Model Number 393-800; UDI (01)05700693938004. Model 393-800 is available in the following configurations: ABL835, ABL830, ABL827, ABL825, ABL825, ABL820, ABL817, ABL815, ABL810, ABL805 and ABL810 BG only and ABL800Basic. The FlexQ module

U.S. FDA — Device Enforcement · Denmark · 2020-05-26 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2493-2020
Date of alert: 2020-05-26
Country / jurisdiction: Denmark
Risk level: Class II
Risk type: recall
Brand: Radiometer Medical ApS
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 05700693938004

Reported risk: Potential risk of patient mix-up on analyzers due to software issues.

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

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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