Recalls / —
—#180907
Product
ARCHITECT C Peptide Calibrator - Product Usage: used as an aid in the diagnosis and treatment of patients with abnormal insulin secretion including diabetes mellitus.
- FDA product code
- JKD — Radioimmunoassay, C-Peptides Of Proinsulin
- Device class
- Class 1
- Medical specialty
- Clinical Chemistry
- Affected lot / code info
- Lot Numbers 01819G000, Exp Date 12JUN2020
Why it was recalled
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.
Root cause (FDA determination)
Employee error
Action the firm took
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.
Recalling firm
- Firm
- Abbott Laboratories
- Address
- 100 Abbott Park Rd, Bldg Ap8b, Abbott Park, Illinois 60064-3502
Distribution
- Distribution pattern
- International distributed only in Mexico, no US distribution.
Timeline
- Recall initiated
- 2020-04-01
- Terminated
- 2020-09-01
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #180907. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.