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U.S. Department of Health and Human Services

Enforcement Report - Week of November 6, 2013

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Product Detail

Product Description COULTERĀ® LH 750 and LH 780 Analyzers. The COULTER LH 750 Hematology Analyzer is a quantitative, automated hematology analyzer and leukocyte differential counter For In Vitro Diagnostic Use in clinical laboratories. The COULTER LH 750 Hematology Analyzer provides automated Reticulocyte analysis and enumeration of nucleated red blood cells (NRBCs) as well as an automated method for enumeration of RBCs and WBCs in body fluids. The COULTER LH 780 Hematology Analyzer is a quantitative, automated hematology analyzer and leukocyte differential counter For In Vitro Diagnostic Use in clinical laboratories. The COULTER LH 780 Hematology Analyzer also provides automated Reticulocyte analysis and enumeration of nucleated red blood cells (NRBCs) as well as an automated method for enumeration of RBCs and WBCs in body fluids.
Recall Number Z-0113-2014
Classification Class II
Code Info Part Numbers: 6605362 for the LH 750 and 723585 for the LH 780. Serial Numbers: AJ08102 AK49053 AM09075 AM10078 AG05059 AK41634 AT02015 AL41189 AJ06078 AF22202 AK34502 AL02001 AS49367 AM10085 AJ10154 AM40321 AS41335 AK32475 AS30241 AU28106 AK36538 AL18073 AL18077 AL37150 AH15237 AL09039 AL09042 AK02032 AJ31547 AJ24410 AM24242 AN13074 AN13075 AN13078 AT18112 AT18115 AG45676 AK46036 AG39545 AJ24402 AJ43796 AK49046 AM05019 AH21364 AH21367 AH21368 AH21369 AH21375 AH23391 AT26118 AN11064 AM02006 AE44164 AJ05072 AJ04046 AJ05065 AJ05073 AN19134 AG17221 AH43790 AM20190 AL39172 AT46205 AH43787 AJ04043 AM17139 AM18149 AS35295 AL52333 AF03026 AL50300 AK49040 AL47248 AK11167 AM35324 AS35299 AF44462 AH47839 AJ28468 AG46712 AK46033 AT36156 AT07053 AH38689 AH43782 AG46711 AN19127 AF02009 AJ06081 AJ07089 AE46202 AF06058 AS49369 AG31388 AG48745 AJ08113 AM23218 AG18236 AG21268 AE45183 AL12053 AU10036 AJ23389 AN04028 AN06034 AM40314 AL50405 AK24368 AL52467 AL51444 AG30381 AN25186 AN25187 AM37348 AL46245 AL47251 AG36485 AH29512 AM44418 AM44421 AT02011 AL10069 AN26201 AM04046 AG12158 AV14043 AT38176 AL29255 AG05053 AJ07099 AK21317 AE36072 AS13058 AU51205 AV11032 AK19285 AN39332 AJ29494 AF33293 AN42337 AM35330 AS38206 AL47259 AL29118 AL29119 AM42341 AM22212 AM23230 AM24238 AJ34618 AS23110 AF42431 AF44470 AT35181 AN38312 AN38313 AH36641 AJ45827 AL11095 AJ24440 AL52320 AL52323 AM38275 AM42391 AM42393 RAU51073 AL43212 AG16203 AT49244 AS23098 AL41323 AE29052 AJ28477 AK22335 AL09035 AL49280 AM21202 AN39330 AN04026 AT49245 AJ42784 AM26261 AM26265 AG14178 AG46706 AM19168 AM38283 AN26202 AS36189 AM29276 AM18145 AL43218 AK21322 AG41591 AM33300 AL11093 AK20292 AS46266 AK48746 AS19124 AH11168 AJ33591 AS23097 AL50399 AT08065 AM16138 AM24177 AM29184 AM36269 AL50425 AK11185 AK11189 AJ41760 AN09048 AN13072 AL47268 AN25184 AJ40726 AJ48869 AN49177 AT07060 AS02013 AH15245 AL19085 AL39166 AL39173 AS38205 AH29492 AJ47001 AM38289 AN17106 AJ49883 AM18155 AM43398 AK34498 AK35514 AL37315 AL45366 AM32232 AL47272 AF49521 AJ50901 AG39549 AG40557 AG40559 AF42434 AH30519 AM46435 AM46437 AT44197 AG46724 AJ08109 AK23353 AG13159 AG41575 AS21144 AS21146 AG45686 AM31209 AH24441 AT31146 AL23215 AM06073 AH40730 AM24171 AJ50906 AJ50909 AJ51913 AH09131 AH09132 AM33312 AM33313 AK43665 AT31153 AJ18298 AJ41744 AS23107 AS21147 AJ42767 AG51792 AF15151 AS46255 AV24083 AL51435 AT31132 AS21079 AK18268 AL47269 AN45350 AM24167 AJ43801 AN32262 AS49371 AH32575 AH31554 AG11149 AN11061 AF11108 AK09151 AK11161 AK09148 AK09158 AV25073 AV25074 AV25075 AE45175 AS41221 AT26107 AM35323 AM14116 AS35296 AK09143 AK05078 AS27212 AL11086 AH07091 AJ39720 AU51184 AU51185 AU51187 AH34619 AN07030 AJ12201 AT49241 AT49242 AH15258 AG32418 AJ12230 AN26135 AT34164 AK50779 AJ42772 AK48739 AS43252 AN15083 AV25069 AV25072 AT23123 AM29187 AN32240 AM33311 AM24169 AM22206 AL52486 AM21157 AT26110 AK45708 AK46719 AN36290 AL18074 AJ25448 AL50410 AL24104 AT05038 AK22011 AF45476 AE45182 AE46190 AF43449 AF44459 AG19243 AG26355 AG37508 AG45688 AG46718 AH03021 AH08104 AH08106 AH21352 AH24437 AH31544 AH35634 AJ19311 AJ24439 AJ34606 AJ35636 AJ35640 AJ35641 AJ36645 AJ36646 AJ36648 AJ36649 AJ36650 AJ36654 AJ38688 AK09149 AK09150 AK23336 AK23337 AK23339 AK23349 AK32472 AK39598 AK40604 AK40606 AK40608 AK40611 AK40618 AK50775 AL22199 AL23209 AL34296 AL45353 AL45358 AL45368 AL50421 AM34233 AM39307 AM40315 AN02008 AN10060 AN13086 AN14091 AN35158 AS07025 AS10050 AS21083 AS21085 AM08053 AJ49877 AE48228 AJ41756 AK44695 AT07072 AJ33587 AJ33588 AM33307 AJ25461 AL39171 AL41181 AH43777 AM20187 AJ22359 AL24109 AH43800 AK24356 AS13073 AJ50900 AM26266 AS32169 AV14040 AS27136 AJ24420 AL50414 AK48745 AN06035 AG04048 AL52469 AJ49873 AT23124 AL09038 AL15072 AM14104 AK17253 AK19276 AT39161 AL31132 AL33147 AJ44807 AJ03037 AS10053 AM40320 AK25383 AH30525 AM44413 AK31452 AK31461 AS02008 AS03011 AN39162 AE41090 AG34474 AS30246 AG48733 AS02010 AJ32567 AJ32571 AM08086 AG23302 AH11171 AH11164 AG34459 AL09036 AT44221 AF20196 AJ17314 AN08046 AS43230 AJ24416 AL47264 AL47266 AK46037 AK49051 AT06026 AH10158 AV10034 AJ39707 AL39161 AN02006 AF44469 AJ29492 AV25067 AV25070 AS30156 AJ11172 AL47256 AT31159 AM43411 AK26395 AL12101 AS41214 AM06062 AM31290 AE44161 AM08079 AJ46864 AM39364 AM39365 AL34304 AN03003 AV04013 AV06019 AG46719 AT49253 AN07028 AF39373 AF46506 AG46723 AJ10151 AJ34611 AK33491 AL32277 AM18153 AM22205 AM22208 AM24246 AM37352 AN09050 AN11057 AN39324 AS02019 AS06032 AS06035 AS13067 AS15085 AS19138 AT06045 AK40616 AH08108 AM18157 AS15081 AM33308 AM33316 AM40371 AS19135 AL50418 AV24081 AV06021 AM03003 AM20192 AK42651 AJ35631 AJ35643 AS19132 AL23101 AM49460 AT12079 AS27127 AS21150 AK33494 AV02008 AV04010 AH29497 AL51440 AK43658 AE42107 RAT40058 AJ24421 AJ25467 AJ25452 AJ28472 AK03045 AE36076 AH31547 AH06070 AH35620 AH08099 AG23301 AG23306 AK20294 AK20297 AJ42778 AG38525 AG40558 AM13107 AK24355 AV25099 AV24078 AV17052 AV10021 AV10022 AV10027 AV17051 AV10026 AV10028 AV10030 AV11031 AV11035 AV14038 AV14039 AV14041 AV19070 AV19073 AV19075 AV24076 AV24080 AV24082 AV24084 AV24085 AV24086 AV24087 AV11033 AV17050 AV19058 AV19059 AV24077 AV07020 AV19057 AV17054 AV19056 AV24079 AV14042 AV19062 AG07083 AJ09135 AV19068 AV14045 AM34250 AT31120 AS13053 AV19069 AV19071 AS16064 AV07018 AV19065 AV19064 AT06032 AJ09141 AL31268 AV19066 AV10029 AK45710 AK17259 AN10069 AK44684 AL32274 AV02003 AN33154 AV10025 AV19072 AT46233 AS13054 AT49252 AL42340 AV19060 AN10065 AG43623 AN02004 AV02005 AN35161 AV14044 AM11102 AJ07095 AH25467 AS07032 AK21313 AT46232 AV02006 AL14118 AM17142 AV14037 AM06070 AV17047 AL41327 AV19063 AT31140 AJ09142 AN19131 AV11034 AH29504 AV19067 AV17049 AG42598 AN19133 AV24089 AV19061 AL50400 AV06012 AV06014 AM06064 AM34247 AG03030 AU06021 AV17048 AV07016 AV06013 AV10024 AM34244 AV24088 AL05025 AJ21349 AJ09132 AJ43791 AL13103 AH15257 AM03017 AK41645 AL05022 AK30435 AH26470 RAS45086 AH14228 AM36258 AM36259 RAU24028 AM36267 AJ29491 AJ44816 AM32230 AH42754 AF49522 AH09122 AH26480 AH38686 AH19291 AH14216 AJ34609 AN33145 RAN39002 AL33283 AM06066 AE43136 AH18286 AE48224 AK24359 AJ15255 AJ50902 AE42115 AJ30518 AE48235 AE48236 RAN39004 AG44662 AH05046 AG45681 AJ30519 AK09146 AH31551 AJ20329 AJ20345 AE42110 AG02019 AM04047 AG19251 AK36535 AG23300 RAV31023 AK49759 RAS27038 AF12126 AK39579 RAS22024 RAS22026 AJ29503 RAS08014 AK20293 AE26042 AM03011 AH15232 AJ24401 AF37338 AG14172 AG22288 AK21312 AG39544 AK50762 AL52477 AL13112 RAS10015 RAS27042 AG13171 AK23338 AL14121 AJ04053 AH06079 AJ20332 RAS10016 AK02023 AE48218 AJ09130 AK05076 AK25384 AK38571 AL51438 AM13118 AH34601 AH50858 AH50868 AK34500 AM05051 AJ42782 AF02007 AJ20339 AL30262 AL33287 AL52472 AK26400 AK20300 AF05029 AG22293 RAS10017 AJ36655 AL08058 AJ42780 AL17155 AJ15256 AG07096 AH15230 AH15233 AL07044 AG26351 AJ09128 AL12102 AJ38701 AM03001 RAS22022 RAS25036 AK01003 AG26344 AH19305 AM03006 AM29179 RAS22027 AH15238 AH19296 RAS10019 AF39376 AM11105 AJ29498 RAS25031 RAS25032 AG25340 AF36330 AM05049 AG22286 AG03040 AL14128 AH50869 AJ15257 AM05054 AJ20337 AJ24434 AJ38702 AK19289 AK50764 AK02025 AK03035 AM05053 AK26402 AM29180 AK19286 AM03020 AG24322 AG24323 AJ38700 AG22289 RAS32047 AF02005 AH15240 AJ22361 AK11169 AK26393 AL33282 AK49756 AM03025 AG25335 AJ42776 AF32272 AK11173 AL30264 AK24361 AG38532 AM08088 AK01004 AJ43802 AK07101 AK29408 AH20325 AJ01001 AK41641 AE44159 AK01005 AJ30520 AH36643 AN17110 AF41426 AL29249 AE26039 AM39296 AH13195 AH14215 AF30260 AK11197 AK12212 AK13223 AK12217 AK32464 AF33287 AH40728 AG43639 AF26232 AJ30527 AF41424 AL20159 AG42612 AK19282 AM08083 AJ07096 AL02020 AL45355 AK25389 AG07091 AJ25454 AJ30521 AF14149 AK30445 AE41092 AK45697 AJ20338 AK32469 AF10105 AK34503 AK06088 AM30195 AM13116 AJ22362 AJ39715 AH32564 AK13221 AH40721 AJ36652 AF12125 AE45176 AM04038 AM04043 AM05048 AK11196 AJ19312 AF37343 AF38352 AK40617 AF11115 AK37554 AG29364 AE45187 AG02016 AG24311 AJ40725 AJ40736 AL22193 AH24449 AH25451 AK31449 AG42607 AG43620 AL08067 AJ12207 AJ12209 AF18177 AJ38695 AK26401 AJ12213 AJ12214 AL21181 AL20173 AL07043 AM42332 AJ43798 RAS32046 RAT18035 AF38348 AK30442 AV07015 RAU38057 AS03016 AV19074 RAV09006 RAT40057 RAU43065 AV25097 RAV31021 RAU31047 RAV05002 AV07019 RAT23046 AT22089 RAV07004 RAV22017 RAV33026 AL52478 RAT40060 RAV16009 RAV22018 AV17046 AV02007 RAV05001 AM38291 AV02004 RAU51072 AM32217 AV02001 RAT31049 AL32278 AL45375 RAU42064 AT31158 AM39304 RAV31022 AS46269 AM21158 AL48387 AT35172 AU51209 RAS02006 AS30146 AL41321 AN33149 AT31154 RAU51071 AT08062 AS10034 AS03014 RAT07012 RAT49088 RAV05003 AV14036 RAT31055 AM30197 AS10046 AS10049 AS30145 AT35175 RAV16013 RAT07011 AK12206 RAT45067 RAT23045 AU45198 AG31403 AK06089 AK11175 AF02002 AF10103 AH13199 AK34512 AL41331 AL42335 AF11119 AG11142 AG11147 AL17152 AL17153 AL33288 AK05079 AJ38693 AK16244 AL22194 AJ19315 AH12185 AL08059 AL07051 AH13200 AH23418 AH24430 AH13193 AJ22367 AK05085 AF30262 AG10130 AK50774 AK50769 AK11177 AG45670 AG45674 AH13202 AH20327 AH13198 AK26405 AF02012 AJ29508 AE42112 AL07047 AF10104 AJ35628 AK11198 AL07042 AK17252 AF40389 AH23392 AK11178 AF09087 AG44653 AG14182 AK02020 AK12203 AG44655 AM05050 AJ07093 AG11146 AH32569 AJ38689 AL06037 AT06030 AK11193 AJ03024 AM08074 AK38563 AF29239 AG42608 AG17217 AJ09138 AL08056 AM34248 AK37548 AL52457 AG43636 AH37664 AL05023 AH06060 AL16140 AL06027 AG03035 AG10133 AG09126 AJ18300 AK50772 AL25226 AK41639 AM06068 AJ03032 AJ04052 AG18234 RAT01002 RAS40074 RAT18032 RAT40065 AF33284 AN14103 AS23102 AM08084 RAT31052 AK19278 AV25091 AG26356 AK19284 AK48741 AM39305 AK08119 AJ22364 AK09155 AK26406 AN49176 AT35182 AT35185 AH26477 AJ22366 AJ33661 AG45685 AL48386 AL45372 AM34237 AL45357 AG26319 AL06033 AK20298 AE33067 AF09089 AH06067 AK01001 AL07050 AE43129 AF12129 AF29247 AH24440 AJ04055 AJ20333 RAS22023 AF302269 AG03036 AJ08125 AF39375 AG07084 AJ42770 24435 AL06028 AE43130 AG13170 AF29240 24444 AH24429 AL12100 AL06032 AH05053 AH15231 AV10023 AV17055 AV24090 AV25098 AV17053 AJ28484 AF34314 RAT31047 AN08050 AT34161 AM40322 AS30154 AS41215 AJ31550 AN06040 AL21179 AU51210 RAV16011 RAV16012 RAT13019 RAT13023 AH23395 AK07111 AJ06079 AJ12206 AK30428 AK39580 AN33150 RAS22025 AF38358 AK11183 AL20161 AL37313 AL37316 AV07017 AV30111 RAV22014 RAV22015 RAS32054 RAS32055 AH24443 AM32220 AM32227 AM42333 AN33143 AJ34602 RAU24034 AK49054 AT38173 AL18080 AN22169 AN25188 AN26194 AK35018 AM02004 AL52334 AU51192 AM43402 AK45024 AV10031 AV06018 AV06020 AV20054 AU10025 AV06017 AV10033 AU51188 AT44193 AT38167 AV20058 AS37324 AV20059 AV25060 AS33274 AT23129 AU10037 AV10032 AL15070 AM06035 AN09051 AM05009 AM05018 AM13098 AM13100 AU41154 AL52350 AL46246 AL31129 AM20176 AS41345 AL46241 AN19137 AN15086 AM15131 AN16096 AL52346 AL01005 AL52342 AL05033 AL02017 AM50470 AS15087 AS15088 AS15092 AN03005 AM49455 AM50461 AM50463 AT07064 AT18100 AN38303 AS33275 AS25184 AN32236 AS06039 AS06041 AS06044 AS30247 AM47447 AS25160 AT05042 AS23170 AT02014 AT12081 AT18099 AS23173 AS23177 AS23178 AN09046 AN22174 AM15122 AM18141 AN32237 AN32241 AS25180 AT05041 AT12080 AN30220 AS10062 AN36274 AS15084 AN22171 AM14111 AM14110 AM14115 AL46239 AN22176 AS33266 AS33270 AS33280 AN38307 AS10055 AS10056 AN36277 AN19129 AN32238 AT36155 AN38302 AT05037 AN18124 AN18125 AN19126 AN19128 AM35327 AS30249 AN09044 AN32242 AS23176 AM23228 AN26206 AS30244 AN03007 AT01003 AL02018 AN38310 AU13047 AM23225 AS35292 AT18110 AM46430 AL43221 AN32254 AN32255 AN32256 AN32257 AL02016 AM14107 AM17134 AS21154 AS06036 AS21152 AT46206 AS27220 AT44191 AM13101 AS30233 AU06017 AL46225 AT44200 AT36163 AL43219 AN07026 AV25071 AU02001 AN39323 AL19090 AT18116 AL39163 AN16102 AM15126 AS18113 AL43220 AN42335 AN39333 AN36285 AM26257 AM18152 AL46228 AT36148 AL19084 AU18064 AM24235 AS21148 AM18148 AM39359 AT18098 AL46231 AU10038 AM35325 AT38165 AN39322 AM09071 AS25187 AN42336 AL05031 AM21193 AM37354 AM46440 AL47249 AM44412 AS19121 AT07062 AM13088 AM15130 AN05012 AN05015 AN05024 AN07031 AN07033 AT18105 AT18107 AM18143 AS06040 AS37310 AS37323 AS41340 AT02019 AS41355 AT12086 AM05008 AL02023 AL05032 AM17136 AM17138 AL09047 AL09049 AL46226 AT12078 AM07049 RAU51025 AT18106 AV04011 AM10083 AV04012 AT44190 AU19084 AU51191 AS15093 AU43167 AV25068 AV07024 AS33282 AT23120 AV25065 AN47361 AM23226 AM24233 AN21155 AN18115 AN18117 AN18118 AN18119 AN18123 AN21152 AN30212 AS15080 AS13072 AS33260 AM24244 AM35332 AM37336 AM49448 AN20143 AN20148 AN05013 AN07035 AN13077 AN13079 AS30239 AN47362 AS33261 AN21158 AN21157 AS18107 AL46229 AL46230 AN30213 AN30215 AN32247 AN32248 AN18122 AU13039 AM46429 AN21151 AM46442 AL01007 AL37157 AM46434 AM08057 AM43409 AS25183 AS49366 AN21164 AS13077 AM15129 AL46233 AN47356 AN18121 AS49363 AS02009 AL46224 AN05018 AS49360 AM46441 AN03010 AN39318 AN39319 AS23174 AN18111 AM50466 AL41177 AL41180 AU02002 AV04009 AM51481 AN13076 AS37332 AL50309 AM05014 AT23127 AL29117 AM13092 AM51475 AM37353 AS27226 AN35269 AS35294 AN18112 AM09069 AU02004 AM41383 AM51482 AM51476 AM13089 AT02012 AM49453 AV06022 AV06023 AV20056 AV20057 RAU51027 RAV11005 RAV11006 RAV16007 RAV16008 RAV25009 RAV25010 RAV27011 RAV27012 RAV27013 AS33265 AS33267 AS33272 AV25062 AL52344 AS27218 AK46027 AL01004 AV20047 AM27251 AS35304 AT12092 AS33283 AM13093 AM13096 AN03009 AN35270 AS10057 AS10060 AT05036 AN32235 AS49372 AS33273 AS33276 AN22173 AN03006 AN32234 AM07050 AM43404 AS15090 AM41374 AM41384 AV20042 AV20044 AV20048 AV20045 AV20046 AV20049 AV20050 AV20051 AV20052 AV20053 AV20055 AL37155 AN20146 AN38304 AS06020 AS19123 AN21165 AS19122 AV06015 AV06016 AV20040 AV20041 AV20043 AN38294 AN11068 AN15093 AN36286 AS25196 AV25076 AV25077 AV25078 AV30080 AV30081 AV30082 AV30083 AV30084 AV30085 AV30086 AV30087 AV30088 AV30089 AS33277 AM43395 AN36284 AS19116 AS27201 AM06029 AN21153 AN21160 AN21161 AN47366 AS02006 AS41353 AS33284 AN20145 AV25066 AS23169 AM31281 AM31296
Product Distributed Qty 1,697 units
Reason For Recall Beckman Coulter internal investigation indicated that specific lots of check valves used in several locations within the LH 750 and LH 780 analyzers may fail. This failure may result in an air or liquid leak at the connection to the Vacuum Overflow Tank waste line or at the Backwash Tank drain line. Source of initial complaint: Customer laboratory in the United States.

Event Detail

Event Id 66383
Product Type Devices
Status Ongoing
Recalling Firm Beckman Coulter Inc.
City Brea
State CA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-09-24
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Worldwide Distribution - Nationwide Distribution and the country of Canada..
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