Recall Z-0101-2014 ยท GKR System, Hemoglobin, Automated
HemoCue AB
HemoCue Hb 201 Microcuvettes, carton/4 boxes/25 pouches of Microcuvettes, HemoCue AB Angelholm, Sweden
| Date | Oct 29, 2013 (initiated Jul 25, 2013) |
| Status | Terminated |
| Reason | HemoCue AB has become aware of a production related problem involving punctured HemoCue Hb 201 Microcuvettes single pack pouches. |
| Root cause | Packaging |
| Action | On 8/13/2013 the firm sent Field Safety Notices to their customers. |
| Quantity | 42,330 packages/4 boxes/25 microcuvetes |
| Distribution | Worldwide distribution which includes the following states: AK, AL, AS, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY,MD, ME, MI, MN, MO, NC, ND, NE, NJ, NM, NY, OH, OK, OR, SC, SD, TN, TX, UT, VA, WA, WI, VT, WV & WY and the countries of Armenia, Australia, Austria, Belgium, Cyprus, Czech Republic, D |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K032203 | HEMOCUE HEMOGLOBIN 201 + SYSTEM ARTICLE 121704 Hemocue, Inc., Aug 25, 2003 |