FDAClass IIIJanuary 16, 2013

Siemens Chek-Stix Combo Pak recall

Siemens Chek-Stix Combo Pak (Distributed OUS only) Catalog Number: 1364M Chek-Stix¿ Positive and Negative Control Strips for Urine Chemistry: When…

Why was Siemens Chek-Stix Combo Pak 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: CP0099091B P0099091B C0100101G P0100101G C0103042E P0103042E

Product
Siemens Chek-Stix Combo Pak (Distributed OUS only) Catalog Number: 1364M Chek-Stix¿ Positive and Negative Control Strips for Urine Chemistry: When…
Recalling firm
Siemens Healthcare Diagnostics Inc
Quantity
325
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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