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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 Positive and Negative Control Strips for Urine Chemistry Catalog Number:1360 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-0635-2013
Classification Class III
Code Info Carton/Bottle Lot Number: C9093061B P9093061B C9094081B P9094081B C0097091B P0097091B C0100101C P0100101C C0103042F P0103042F C0106062B P0106062B C91 01022D P91 01022D CP9105052B P9105052B C9108092A P9108092A
Product Distributed Qty 7865
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,