Recall Z-1356-2019
Abbott Laboratories · initiated April 9, 2019
Class III – products unlikely to cause any adverse health reaction but that violate FDA labeling or manufacturing laws
Product
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.
Codes / lots: LN 4P72-01; Lot 902920500
Reason for recall
Devices were delivered without the required dry ice.
FDA-determined cause: Under Investigation by firm
Action taken
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.
Details
- Recall number
- Z-1356-2019
- Initiated
- April 9, 2019
- Terminated
- December 20, 2019
- Product code
- JIT – Calibrator, Secondary
- Quantity
- 1 unit
- Distribution
- Distribution to Latvia.
- Recalling firm
- Abbott Laboratories, Abbott Park, IL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1355-2019 Class III | ARCHITECT Sirolimus Calibrators - Product Usage: The ARCHITECT Sirolimus Calibrators are…Devices were delivered without the required dry ice. | 04/09/2019Terminated |
| Z-1357-2019 Class III | ARCHITECT Intact PTH Controls - Product Usage: The ARCHITECT Intact PTH Calibrators are…Devices were delivered without the required dry ice. | 04/09/2019Terminated |
| Z-1358-2019 Class III | ARCHITECT Intact PTH Calibrators - Product Usage: The ARCHITECT Intact PTH Calibrators…Devices were delivered without the required dry ice. | 04/09/2019Terminated |
| Z-1359-2019 Class III | ARCHITECT STAT High Sensitive Troponin-I Controls - Product Usage: The ARCHITECT STAT…Devices were delivered without the required dry ice. | 04/09/2019Terminated |
| Z-1360-2019 Class III | ARCHITECT STAT High Sensitive Troponin-I Calibrators - Product Usage: The ARCHITECT STAT…Devices were delivered without the required dry ice. | 04/09/2019Terminated |
| Z-1361-2019 Class III | ALINITY i Anti-TPO Calibrators - Product Usage: The Alinity i Anti-TPO Calibrators are…Devices were delivered without the required dry ice. | 04/09/2019Terminated |
| Z-1362-2019 Class III | Technopath Multichem S Plus Level 1 - Product Usage: Multichem S Plus (Assayed) is…Devices were delivered without the required dry ice. | 04/09/2019Terminated |
| Z-1363-2019 Class III | Technopath Multichem S Plus Level 2 - Product Usage: Multichem S Plus (Assayed) is…Devices were delivered without the required dry ice. | 04/09/2019Terminated |