DxI 9000 Access Immunoassay Analyzer recall
DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, with Component PCB, TSI/RSI firmware C29278
Why was DxI 9000 Access Immunoassay Analyzer recalled?
Beckman Coulter identified that an issue for DxI 9000 tip stocker interface (TSI) and reagent storage interface (RSI) boards with the firmware version 1.1.0.0 can cause sub-system communication failures. This failure could result in a delay in reporting patient results.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI-DI: 15099590732103; Serial Numbers: 300158 300161 300164 300167 300169 300175 300178 300179 300182 300183 300185 300189 300194 300197 300201 300202 300204 300210 300216 300217 300218 300220 300224 300225 300233 300234 300236 300237 300239 300240 300241 300243 300244 300246 300247 300252 300255 300256 300260 300267 300270 300272 300273 300275 300280 300288 300290 300295 300296 300299 300300 300304 300313 300314 300317 300318 300321 300322 300323 300324 300333 300334 300336 300338 300339 300341 300351 300362 300364 300368 300370 300373 300374 300375 300379 300380 300385 300386 300388 300389
- Product
- DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137, with Component PCB, TSI/RSI firmware C29278
- Recalling firm
- Beckman Coulter, Inc.
- Quantity
- 80 units
- Distribution
- Worldwide - US Nationwide distribution in the states of FL, TX, WA.
- Recall date
- March 26, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)