Recall Z-1356-2019 ยท JIT Calibrator, Secondary
Abbott Laboratories
ARCHITECT HbA1C Calibrators - Product Usage: The ARCHITECT HbA1c Calibrators are for the calibration of the ARCHITECT i System when used for the quantitative determination of percent hemoglobin A1c (HbA1c) in human whole blood.
| Date | Apr 9, 2019 |
| Status | Terminated |
| Reason | Devices were delivered without the required dry ice. |
| Root cause | 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 o |
| Quantity | 1 unit |
| Distribution | Distribution to Latvia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K121842 | ARCHITECT HBA1C, ARCHITECT HBA1C, AND ARCHITECT HBA1C Axis-Shield Diagnostics, Ltd., Dec 12, 2012 |