| Date Initiated by Firm |
July 09, 2019 |
| Create Date |
August 26, 2019 |
| Recall Status1 |
Terminated 3 on July 12, 2022 |
| Recall Number |
Z-2397-2019 |
| Recall Event ID |
83402 |
| 510(K)Number |
K051218
|
| Product Classification |
System, test, radioallergosorbent (rast) immunological - Product Code DHB
|
| Product |
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 |
All Serial Numbers; Unique Device Identifier (UDI): 07333066001005 |
Recalling Firm/
Manufacturer |
Phadia Ab
Rapsgatan Plant
Rapsgatan 7
Uppsala Sweden
|
Manufacturer Reason
for Recall |
code 7-102 Liquid Sensor Error
|
FDA Determined
Cause 2 |
Under Investigation by firm |
| Action |
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 |
| Quantity in Commerce |
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 |
| Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
| 510(K) Database |
510(K)s with Product Code = DHB and Original Applicant = PHARMACIA DIAGNOSTICS AB
|
