FDAClass IIDecember 26, 2018

Staclot¿ LA recall

Staclot¿ LA (REF 00600) The Staclot¿ LA and Staclot¿ LA 20 test kits are reagent systems designed for the qualitative detection of lupus…

Why was Staclot¿ LA recalled?

There have been reports of shortened (T1-T2) results, where some instances of result recovery outside of the range of less than or equal to 15 seconds.

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?

Lot #s 251918, 252751

Product
Staclot¿ LA (REF 00600) The Staclot¿ LA and Staclot¿ LA 20 test kits are reagent systems designed for the qualitative detection of lupus…
Recalling firm
Diagnostica Stago, Inc.
Quantity
22342 total
Distribution
US Nationwide Distribution
Recall date
December 26, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls