FDAClass IIIJanuary 16, 2013

Siemens Chek-Stix Combo Pak recall

Siemens Chek-Stix Combo Pak Catalog Number: 1364 Chek-Stix¿ Positive and Negative Control Strips for Urine Chemistry: When used with Siemens reagent…

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: C9093061C P9093061C C9094081J P9094081J C0100101D P0100101D C0097091E P0097091E C9101022E P9101022E C0099091D P0099091D C0100101E P0100101E C9101022H P9101022H C9101022J P9101022J C0103042B P0103042B C0103042G P0103042G C0106062D P0106062D C9105052C P9105052C

Product
Siemens Chek-Stix Combo Pak Catalog Number: 1364 Chek-Stix¿ Positive and Negative Control Strips for Urine Chemistry: When used with Siemens reagent…
Recalling firm
Siemens Healthcare Diagnostics Inc
Quantity
16711
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)
Open FDA enforcement record Latest recalls