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U.S. Department of Health and Human Services

Class 2 Device Recall HemoCue Hb 201 Microcuvettes

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  Class 2 Device Recall HemoCue Hb 201 Microcuvettes see related information
Date Initiated by Firm July 25, 2013
Date Posted October 29, 2013
Recall Status1 Terminated 3 on August 11, 2014
Recall Number Z-0101-2014
Recall Event ID 65920
510(K)Number K032203  
Product Classification Automated hemoglobin system - Product Code GKR
Product HemoCue¿ Hb 201 Microcuvettes, carton/4 boxes/25 pouches of Microcuvettes, HemoCue AB Angelholm, Sweden
Code Information Part Number 111715: Lot numbers1208655, 1208658, 1208659, 1208660, 1208663, 1208664, 1209667, 1209669, 1209670, 1209671, 1209672, 1209674, 1209675, 1209677, 1209678, 1210681, 1210683, 1210685, 1210688, 1211690, 1211691, 1211692, 1211694, 1211696, 1211697, 1211699, 1212701, 1212702, 1212703, 1212705, 1212706, 1301708, 1301710, 1301711, 1301712, 1301715, 1301717, 1301719, 1302721, 1302723, 1302725, 1302726, 1303729, 1303734 & 1304737.   Part Number 111717: Lot Numbers: 1208657, 1208661, 1208662, 1208665, 1209666, 1209668, 1209673, 1209676, 1210679, 1210680, 1210682, 1210684, 1210686, 1210689, 1211693, 1211695, 1211698, 1212700, 1212704, 1212707, 1301709, 1301713, 1301714, 1301716, 1301718, 1302720, 1302722, 1302724 & 1304738.   Part Number 111722: Lot numbers: 1209672, 1210687, 1212701 & 1303727.  Part Number 116101; Lot Numbers: 1303730 & 1303735.
Recalling Firm/
Manufacturer		 HemoCue AB
Kuvettgaten 1
Angelholm Sweden
For Additional Information Contact Mr. Shane T. Hawes
440-871-0463
Manufacturer Reason
for Recall		 HemoCue AB has become aware of a production related problem involving punctured HemoCue Hb 201 Microcuvettes single pack pouches.
FDA Determined
Cause 2		 Packaging
Action On 8/13/2013 the firm sent Field Safety Notices to their customers.
Quantity in Commerce 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, Denmark, El Salvador Finland, France, Germany, Great Britain, Guatemala, Hong Kong, Israel, Ivory Coast, Netherlands, New Zealand, Norway, Peru, Poland, Russia, South Africa, Sweden, Switzerland and Taiwan.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = GKR and Original Applicant = HEMOCUE, INC.
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