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Z-2397-2019 Class II Terminated

Recalled by Phadia Ab — Uppsala, N/A

FDA device recall Z-2397-2019 was initiated by Phadia Ab on July 9, 2019 and is designated Class II. Reason for recall: code 7-102 Liquid Sensor Error The recall status is terminated (terminated July 12, 2022). Affected quantity: 387 Instruments.

Recall Details

Product Type: Devices
Report Date: September 4, 2019
Initiation Date: July 9, 2019
Termination Date: July 12, 2022
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 387 Instruments

Product Description

Phadia" 1000 Model # 12-3800-01 Product Usage: The instrument is fully integrated and automated instrument including software for immunodiagnostic testing. The instrument is designed to handle all steps from sample and reagent handling to processing of results.

Reason for Recall

code 7-102 Liquid Sensor Error

Distribution Pattern

US Nationwide Distribution in the states of CA CO FL GA HI IL IN KS KY MA MD MI MO NC NJ NV NY OH OK OR PA TN TX UT VA WA

Code Information

All Serial Numbers; Unique Device Identifier (UDI): 07333066001005

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