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Recall Observatory FDA recall evidence

Device product

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

Z-0641-2013

November 21, 2012

Class III

Product summary

Firm
Siemens Healthcare Diagnostics Inc
Event
Event 63809
Status
Terminated
Classification
Class III
Quantity
4642
Official record key
device-enforcement:Z-0641-2013

Official wording

Reason: 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).

Code information: Carton/Bottle Lot Number: C0099091C P0099091C C0100101F P0100101F C9101022I P9101022I C0103042D P0103042D C0106062E P0106062E

Distribution pattern: Worldwide Distribution - USA (nationwide) and internationally to Canada, Aruba, Brazil, Denmark, India, Mexico, New Zealand, Singapore,Thailand, Bahamas, South Wales, and Hong Kong,

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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).