FDAClass IIIMay 14, 2014

CLINITEK Status+ Analyzer recall

CLINITEK Status+ Analyzer (portable urine chemistry analyzer). Catalog number 10490946.

Why was CLINITEK Status+ Analyzer recalled?

Device with Sample Interference Notes (SIN) enabled not cleared for US marketing.

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?

Serial Number: 212809

Product
CLINITEK Status+ Analyzer (portable urine chemistry analyzer). Catalog number 10490946.
Recalling firm
Siemens Healthcare Diagnostics Inc
Quantity
1 unit
Distribution
US Distribution in the state of: CA.
Recall date
May 14, 2014
Classification
Class III
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls