FDAClass IIIJanuary 16, 2013

Siemens Chek-Stix Positive and Negative Control Strips recall

Siemens Chek-Stix Positive and Negative Control Strips for Urine Chemistry (Distributed OUS Only) Catalog Number: 1360L Chek-Stix¿ Positive and…

Why was Siemens Chek-Stix Positive and Negative Control Strips recalled?

When these lots of control material are reconstituted, the positive control solution leukocyte result may become negative if the solution is held for more than two hours above 25¿C (77¿F).

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?

Carton/Bottle Lot Number: C9094081C P9094081C C0100101A P0100101A C9101022C P9101022C

Product
Siemens Chek-Stix Positive and Negative Control Strips for Urine Chemistry (Distributed OUS Only) Catalog Number: 1360L Chek-Stix¿ Positive and…
Recalling firm
Siemens Healthcare Diagnostics Inc
Quantity
700
Distribution
Worldwide Distribution - USA (nationwide) and internationally to Canada, Aruba, Brazil, Denmark, India, Mexico, New Zealand, Singapore,Thailand, Bahamas, South Wales, and Hong Kong,
Recall date
January 16, 2013
Classification
Class III
Status
Terminated
Agency
FDA (device)
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