United StatesDxC 500i Clinical Analyzer modules (part numbers C63522, C63521, C13252) and DxI 9000 Access Immunoassay Analyzer (part number C11137) are affected; units are identified by the listed UDI-DIs and serial numbers. Beckman Coulter recalled them because a software anomaly may prevent correct application of user‑specified manual dilution factors when ordering additional tests for samples already “In Progress” using the same Sample ID number, which can produce false low or high patient results and delay reporting, risking erroneous diagnoses if undetected.
What's being recalled
DxC 500i Clinical Analyzer Modules, DxC 500 AU Module w/ISE, DxC 500i (Part Number C63522), DxC 500 AU Module, DxC 500i (Part Number C63521), and Access 2 Module, DxC 500i (Part Number C13252)
DxI 9000 Access Immunoassay Analyzer, Part Number C11137
Recalling firm: Beckman Coulter, Inc., Chaska, MN, United States.
How to identify it
C63522 UDI-DI: 14987666545089; C63521 UDI-DI: 14987666545072; C13252 UDI-DI: 15099590742331; Serial Numbers: 750198 750058 750222 750128 750138 750069 750050 750055 750179 750180 750181 750109 750168 750104 750211 750073 750210 750209 750178 750151 750153 750152 750155 750185 750187 750188 750195 750196 750201 750197 750199 750204 750202 750205 750083 750079 750186 750052 750230 750228 750140 750077 750135 750130 750167 750095 750105 750175 750132 750082 750113 750221 750219 750100 750099 750174 750053 750246 750134 750217 750216 750236 750233 750143 750081 750085 750071 750208 750207 750076 750131 750148 750223 750137 750116 750166 750241 750240 750183 750193 750200 750070 750087 750239 750107 750093 750124 750215 750141 750145 750144 750117 750108 750184 750173 750224 750218 750123 750129 750054 750206 750146 750101 750112 750194 750115 750157 750159 750160 750162 750125 750103 750229 750226 750234 750133 750048 750163 750182 750192 750189 750158 750250 750214 750110 750247 750154 750080 750251 750232 750231 750255 750238 750253 750074 750047 750102 750147 750142 750092 750094 750164 750165 750225 750212 750064 750065 750177 750086 750088 750042 750043 750254 750044 750056 750169 750045 750057 750127 750156 C11137 UDI-DI: 15099590732103; Serial Numbers: 300621 300655 300564 300572 300411 300425 300576 300577 300625 300295 300713 300714 300289 300497 300333 300520 300524 300440 300443 300441 300444 300445 300528 300515 300332 300466 300484 300412 300395 300541 300255 300270 300499 300435 300436 300467 300532 300560 300600 300604 300605 300607 300609 300610 300707 300709 300710 300596 300597 300374 300679 300677 300558 300559 300593 300584 300169 300239 300124 300225 300595 300638 300495 300496 300381 300668 300237 300156 300571 300641 300131 300637 300488 300142 300141 300143 300151 300152 300316 300546 300298 300299 300328 300414 300413 300422 300132 300534 300317 300318 300567 300568 300163 300162 300276 300277 300174 300226 300370 300459 300386 300503 300388…
The hazard
Beckman Coulter has confirmed a software anomaly on DxI 9000 Access Immunoassay Analyzer and the DxC 500i Clinical Analyzer that may prevent correct application of user-specified manual dilution factors when ordering additional tests for samples already "In Progress" using the same "Sample ID number". This can lead to false low or high patient results and potential delays in reporting, risking erroneous diagnoses if undetected.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
Worldwide - US Nationwide distribution.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)
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