ARCHITECT Intact PTH Controls - 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.
Recall
- Recall Number
- Z-1357-2019
- Event Number
- 82590
- Firm
- Abbott Laboratories
- FEI Number
- 1415939
- Product Code
- JJX
- Status
- Terminated
- Root Cause
- Under Investigation by firm
- Initiated
- April 9, 2019
- Terminated
- December 20, 2019
- Address
- 100 Abbott Park Rd, Bldg Ap8b, Abbott Park, IL, 60064-3502
Description
ARCHITECT Intact PTH Controls - 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.
Devices were delivered without the required dry ice.
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.
Distribution to Latvia.
1 unit