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Terminated

Phadia 1000 Instrument, Article Number 12-3800-01.

FDA Recall Z-0387-2018 · Posted None

Recalling FirmPhadia US Inc
Recall StatusTerminated
Product CodeDHB
Date Initiated2017-07-05
Date Terminated2018-10-04
Product Quantity70 units

Reason for Recall

The "Retry" command does not function properly which could cause a shortage of Wash and Rinse solution and affect assay performance and test results.

Firm Action

The firm sent letters with a return response form to customers. The firm instructed customers to immediately choose the "stop" command if presented with the 7-101 Liquid Sensor Error. Results from the assay should not be approved. A revision of the current software will have a mandatory installation soon.

Root Cause

Device Design

Distribution Pattern

Nationwide

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K161899ImmunoCAP Total IgE Calibrator Strip/Total IgE Curve Control Strip, ImmunoCAP Total IgE Calibrators/Total IgE Curve Controls, ImmunoCAP Specific IgE Calibrator Strip/Specific IgE Curve Control Strip, ImmunoCAP Specific IgE Calibrators/Specific IgE Curve ControlsPhadia AB · 2016-07-28

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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