FDAClass IINovember 11, 2015

ELITech Clinical Systems reagents used on the Selectra recall

ELITech Clinical Systems reagents used on the Selectra ProS and ProM systems that utilize the Trinder Reaction method. The following product reference…

Why was ELITech Clinical Systems reagents used on the Selectra recalled?

ELITech Clinical Systems reagents based on Trinder reaction used on the Selectra ProS and ProM systems are recalled due to potential drug interference. No complaints were received.

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?

all lots

Product
ELITech Clinical Systems reagents used on the Selectra ProS and ProM systems that utilize the Trinder Reaction method. The following product reference…
Recalling firm
ELITech Clinical Systems SAS
Quantity
969 systems
Distribution
US Nationwide Distribution
Recall date
November 11, 2015
Classification
Class II
Status
Terminated
Agency
FDA (device)
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