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Phadia" 1000 recallZ-2397-2019 · Phadia Ab · initiated Jul 9, 2019

Terminated

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Phadia Ab or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

code 7-102 Liquid Sensor Error

FDA root cause category: Under Investigation by firm

What the company is doing

The following actions are to be taken: 1. Use of the Phadia" 1000 can continue as detailed in the users manual with the following changes: If the error 7-102 occurs, ensure that the error is handled as stated below: A. Select Retry if the error occurs outside of Assay run. This selection has no effect on assay performance in this situation. B. Select Retry if the error occurred within Assay run in the previous six minutes. This selection has no effect on assay performance in this situation. Note: If you are unsure of the six minutes related to the error occurrence, select Stop. C. Select Stop if the error occurred within Assay run after six minutes as indicated in the system software. Note: Performing a Retry or Stop after six minutes presents a risk that assay performance and results are affected. Selecting Stop will stop ImmunoCAP dispensing and all processing tests will be flagged as erroneous. Corrective actions can then be performed. 2. Whether you select Retry or Stop, contact Technical Support after attending to error 7-102 according to the instructions above to provide notification to our technical department and to receive additional guidance. Additionally; Ensure that the sound alarm is audible and that the visible alarm is visible within the laboratory. Ensure that the criteria according to the user manual for incoming water (rinse solution) is met. Further, it is recommended to ensure that Monthly Maintenance with 1% Sodium Hypochlorite (bleach) solution is performed according to the user manual. Ensure Rinse and Wash Bottle Float/Stems are correctly installed in their respective bottles and are refilled in a timely manner when the instrument is operated. Ensure Stop Solution bottles are full at the start of Assay run, otherwise switch bottle connector to second bottle loaded prior to the first becoming empty. Note: Stop Solution bottles contain 1200 doses. If you have any questions, please

Recall details

Recall number
Z-2397-2019
Status
Terminated
Initiated by the company
Jul 9, 2019
Recalling firm
Phadia Ab
Quantity
387 Instruments
Product code
DHB
FDA submissions
K051218
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

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.

Code information (models, lots, serial numbers)

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

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Other devices under the same FDA submission

1 device cleared under K051218 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

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