Recall Z-0086-2014 ยท KQO Automated Urinalysis System
HemoCue AB
HemoCue Urine Albumin Microcuvettes, 25 Microcuvettes HemoCue AB Angelholm, Sweden The quantitative, rapid, turbidimetric immunoassay of albumin in human urine using a specially designed analyzer, the HemoCue Albumin 201 Analyzer. The system can be used for the quantitative determination of low levels of albumin in urine for the purpose of screening for, diagnosing, monitoring and to supplement t
| Date | Oct 25, 2013 (initiated Jul 16, 2013) |
| Status | Terminated |
| Reason | HemoCue AB has become aware of a production related problem involving punctured HemoCue Urine Albumin Microcuvettes single pack pouches. |
| Root cause | Packaging |
| Action | HemoCue sent an Urgent Field Safety Notice dated July 24, 2013. to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to : 1. Quarantine any HemoCue Urine Albumin (110608); lot numbers 1208848 to 1304847 you may have in your possession 2. Return the Field Safety Notice Verification Form to: fax: 562-668-5794 We apologize for the inconvenience this advisory has caused you. Please feel free to contact Technical Support at 800-426-7256 with any questions. |
| Quantity | 10,356 boxes/50 microcuvettes |
| Distribution | Worldwide Distribution - Nationwide Distribution including the states of AL, AR, AZ, CA, CA ,CT, FL, GA, HE, ID, IL, IN, LA, MA, ME, MI, MN, MO, MS, NC, NH, NM, NY, OH, PA, SC,TX, UT, VA, VT, WA and WI., and the countries of Australia, Bahrain, Belarus, Canada, Czech Republic, Denmark, Finland, Fr |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K053253 | HEMOCUE ALBUMIN 201 ANALYZING SYSTEM Hemocue AB, Feb 17, 2006 |