FDAClass IISeptember 4, 2019

Phadia" 1000 recall

Phadia" 1000 Model # 12-3800-01 Product Usage: The instrument is fully integrated and automated instrument including software for immunodiagnostic…

Why was Phadia" 1000 recalled?

code 7-102 Liquid Sensor Error

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
Phadia" 1000 Model # 12-3800-01 Product Usage: The instrument is fully integrated and automated instrument including software for immunodiagnostic…
Recalling firm
Phadia Ab
Quantity
387 Instruments
Distribution
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
Recall date
September 4, 2019
Classification
Class II
Status
Terminated
Agency
FDA (device)
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