Recall Z-1893-2020
Abbott Laboratories · initiated April 1, 2020
Class III – products unlikely to cause any adverse health reaction but that violate FDA labeling or manufacturing laws
Product
ARCHITECT C Peptide Reagent - Product Usage: used as an aid in the diagnosis and treatment of patients with abnormal insulin secretion including diabetes mellitus.
Codes / lots: Lot Numbers 01719F000 (Exp Date 14MAY2020), 02519E000 (Exp Date 09APR2020)
Reason for recall
Error in the renewal documentation process for license in Mexico. All in date ARCHITECT C Peptide Reagents, Calibrators and Controls are being recalled until a new license is obtained.
FDA-determined cause: Employee error
Action taken
Abbott Laboratories notified customers on about 04/01/2020 via Product Recall letter. Instructions included to discontinue use and destroy any inventory of ARCHITECT CPeptide Reagents, Calibrators and Controls listed in the table above according to laboratory procedures. Instructions also included to complete and return the Customer Reply Form and to notify customers if product is further distributed.
Details
- Recall number
- Z-1893-2020
- Initiated
- April 1, 2020
- Terminated
- September 1, 2020
- Product code
- JIT – Calibrator, Secondary
- Quantity
- 65 kits total
- Distribution
- International distributed only in Mexico, no US distribution.
- Recalling firm
- Abbott Laboratories, Abbott Park, IL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1894-2020 Class III | ARCHITECT C Peptide Calibrator - Product Usage: used as an aid in the diagnosis and…Error in the renewal documentation process for license in Mexico. All in date ARCHITECT C Peptide Reagents… | 04/01/2020Terminated |
| Z-1895-2020 Class III | ARCHITECT C Peptide Calibrator - Product Usage: used as an aid in the diagnosis and…Error in the renewal documentation process for license in Mexico. All in date ARCHITECT C Peptide Reagents… | 04/01/2020Terminated |