Reported Jan 16, 2013 · Terminated

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

Siemens Healthcare Diagnostics Inc.

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Siemens Healthcare Diagnostics Inc · 2 Edgewater Dr · Norwood, MA · 02062-4637

Is this the product you have?

  • Siemens
  • Chek-Stix Combo Pak Catalog Number1364 Chek-Stix¿ Positive and Negative
  • Control Strips for Urine ChemistryWhen used with Siemens reagent strips and tablets for urinalysis, CHEK-STIX¿ positive and negative control strips provide defined results for glucose, bilirubin, ketone (acetoacetic acid), specific gravity, blood, pH, protein, urobilinogin, nitrite, and leukocytes
Lot codes and dates
  • 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
Amount recalled
16711

This recall covers 7 products

The agency filed one notice per product. You are reading one of them; the other 6 are below.

Where it was sold

  • Nationwide

Why it was 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).

This product is unlikely to cause harm, but it breaks a safety or labelling rule.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Nov 6, 2014 · Data as of Sep 19, 5:33 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.