FDAClass IIOctober 17, 2012

IDS Urine BETA CrossLaps ELISA recall

IDS Urine BETA CrossLaps ELISA, Catalog Number AC-05F1. Type of packaging: Cardboard Box containing plastic bottles. The Urine BETA CrossLaps¿ ELISA…

Why was IDS Urine BETA CrossLaps ELISA recalled?

It has been noted by staff at IDS Inc. that stock of the affected products held at IDS Inc. are labeled with IVD labels although they are not registered for sale as IVDs in the United States. The products should have been labeled as Research Use Only or Investigational use only dependent on their usage.

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 14541, EXP Nov 2012

Product
IDS Urine BETA CrossLaps ELISA, Catalog Number AC-05F1. Type of packaging: Cardboard Box containing plastic bottles. The Urine BETA CrossLaps¿ ELISA…
Recalling firm
Immunodiagnostics Systems Ltd
Quantity
1
Distribution
Nationwide Distribution including NY, CA, ME and CT.
Recall date
October 17, 2012
Classification
Class II
Status
Terminated
Agency
FDA (device)
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