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U.S. Department of Health and Human Services

Enforcement Report - Week of January 16, 2013

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Product Detail

Product Description 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
Recall Number Z-0641-2013
Classification Class III
Code Info Carton/Bottle Lot Number: C0099091C P0099091C C0100101F P0100101F C9101022I P9101022I C0103042D P0103042D C0106062E P0106062E
Product Distributed Qty 4642
Reason For Recall 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).

Event Detail

Event Id 63809
Product Type Devices
Status Ongoing
Recalling Firm Siemens Healthcare Diagnostics Inc
City Norwood
State MA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-11-21
Initial Firm Notification of Consignee or Public Letter
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,