Date Initiated by Firm | April 09, 2019 |
Create Date | May 16, 2019 |
Recall Status1 |
Terminated 3 on December 20, 2019 |
Recall Number | Z-1358-2019 |
Recall Event ID |
82590 |
510(K)Number | K063232 |
Product Classification |
Calibrator, secondary - Product Code JIT
|
Product | ARCHITECT Intact PTH Calibrators - Product Usage: The ARCHITECT Intact PTH Calibrators are for the calibration of the ARCHITECT iSystem when used for the quantitative determination of Intact PTH in human serum and plasma. |
Code Information |
LN 8K25-04; Lot 01018H000 |
Recalling Firm/ Manufacturer |
Abbott Laboratories 100 Abbott Park Rd Bldg Ap8b Abbott Park IL 60064-3502
|
For Additional Information Contact | Albert Chianello 224-668-1923 |
Manufacturer Reason for Recall | Devices were delivered without the required dry ice. |
FDA Determined Cause 2 | Under Investigation by firm |
Action | On about 04/04/2019, Abbott notified customers in Latvia of the recall. Instructions included to examine inventory for any affected devices on hand, review the letter with your Medical Director or Laboratory Management and
follow your laboratory protocol regarding the need for reviewing previously reported patient results, complete and return the Customer Reply form, and notify customers if the affected devices have been forwarded to other laboratories and provide them a copy of the notification letter.
If replacement material is available, customers were instructed to discontinue the use of affected devices and destroy any remaining inventory according to your laboratory procedures. If replacement material is not available, immediately order replacement material. Abbott instructed customers that they may continue to use the impacted material as long as controls are within range. Destroy
impacted material once replacement material is available. |
Quantity in Commerce | 2 units |
Distribution | Distribution to Latvia. |
Total Product Life Cycle | TPLC Device Report |
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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.
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510(K) Database | 510(K)s with Product Code = JIT
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