FDAClass IIIMay 22, 2019

ARCHITECT STAT High Sensitive Troponin-I Calibrators recall

ARCHITECT STAT High Sensitive Troponin-I Calibrators - Product Usage: The ARCHITECT STAT High Sensitive Troponin-I Controls are for the estimation of…

Why was ARCHITECT STAT High Sensitive Troponin-I Calibrators 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 3P25-02; Lot 93284UIOO

Product
ARCHITECT STAT High Sensitive Troponin-I Calibrators - Product Usage: The ARCHITECT STAT High Sensitive Troponin-I Controls are for the estimation of…
Recalling firm
Abbott Laboratories
Quantity
3 units
Distribution
Distribution to Latvia.
Recall date
May 22, 2019
Classification
Class III
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls