FDAClass IIIMay 22, 2019

ARCHITECT HbA1C Calibrators - Product Usage: The recall

ARCHITECT HbA1C Calibrators - Product Usage: The ARCHITECT HbA1c Calibrators are for the calibration of the ARCHITECT i System when used for the…

Why was ARCHITECT HbA1C Calibrators - Product Usage: The recalled?

Devices were delivered without the required dry ice.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

LN 4P72-01; Lot 902920500

Product
ARCHITECT HbA1C Calibrators - Product Usage: The ARCHITECT HbA1c Calibrators are for the calibration of the ARCHITECT i System when used for the…
Recalling firm
Abbott Laboratories
Quantity
1 unit
Distribution
Distribution to Latvia.
Recall date
May 22, 2019
Classification
Class III
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls