FDAFDA · Food and drugs·Recall number Z-0113-2014
COULTER 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.
Published November 6, 2013 · Recall initiated: September 24, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The check valves may fail on the Coulter LH 750 Hematology Analyzer (PN 6605632 and A85570) and Coulter LH 780 Hematology Analyzer (PN 723585 and A90728). A 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Beckman Coulter Inc.
- Distributor
- Worldwide Distribution - Nationwide Distribution and the country of Canada..
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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