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 (Distributed OUS Only) Catalog Number: 1360L 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-0638-2013 |
| Classification | Class III |
| Code Info | Carton/Bottle Lot Number: C9094081C P9094081C C0100101A P0100101A C9101022C P9101022C |
| Product Distributed Qty | 700 |
| 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, |
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