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)
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Beckman Coulter, Inc.
- Reason for Recall:
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
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)
Product Codes/Lot Numbers:
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
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0215-2026
Related Recalls
It has been determined that certain lots of Access 2 Reaction Vessels may contain manufacturing deformities. The bottom (round end) of the Reaction Vessel may have a small protrusion or hair like deformity. This could cause causing instrument errors (e.g., pipetting, rake, wash carousel errors) that could delay patient results.
Due to a software error code that crashes during acquisition on patient sample when running customer defined acquisition protocol. This may lead to delayed patient results.
Beckman Coulter UniCel DxI 600, Part Numbers: A71460, A30260; Photometric Chemistry Analyzer
Beckman Coulter
An internal investigation has determined that due to defective sub-components within the gantry assembly, a z-axis CAD movement motion error may occur and cause an analyzer to enter a Not Ready or Paused state, leading to a delay in obtaining results.