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Recall Observatory FDA recall evidence

Device product

HemoCue¿ Hb 201 Microcuvettes, carton/4 boxes/25 pouches of Microcuvettes, HemoCue AB Angelholm, Sweden

Z-0101-2014

July 25, 2013

Class II

Product summary

Firm
HemoCue AB
Event
Event 65920
Status
Terminated
Classification
Class II
Quantity
42,330 packages/4 boxes/25 microcuvetes
Official record key
device-enforcement:Z-0101-2014

Official wording

Reason: HemoCue AB has become aware of a production related problem involving punctured HemoCue Hb 201 Microcuvettes single pack pouches.

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.

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    HemoCue AB has become aware of a production related problem involving punctured HemoCue Hb 201 Microcuvettes single pack pouches.