DxI 9000 Access Immunoassay Analyzer C11137
Class I - DangerousWhat Should You Do?
- Check if you have this product: UDI-DI 15099590732103 Serial Numbers 300116 300124 300126 300128 300132 300136 300138 300144 300145 300148 300150 300153 300154 300155 300156 300157 300158 300161 300166 300168 300171 300174 300175 300178 300179 300182 300183 300186 300190 300191 300192 300193 300194 300198 300200 300201 300204 300205 300206 300207 300208 300209 300210 300211 300212 300213 300214 300215 300217 300218 300219 300221 300225 300226 300228 300231 300232 300234 300235 300236 300240 300242 300246 300249 300250 300252 300255 300266 300267 300270 300272 300273 300274 300275 300279 300280 300282 300283 300284 300285 300286 300288 300293 300299 300300 300306 300307 300308 300309 300312 300314 300316 300317 300318 300319 300321 300322 300323 300326 300327 300328 300329 300331 300333 300334 300336 300338 300339 300341 300346 300350 300352 300354 300355 300356 300358 300359 300360 300361 300362 300370 300372 300373 300375 300376 300378 300388 300389 300392 300393 300395 300396 300397 300398 300403 300407 300408 300409 300410 300411 300413 300414 300415 300420 300422 300423 300424 300425 300426 300427 300428 300430 300434 300438 300446 300454 300455 300457 300458 300461 300464 300467 300468 300470 300474 300475 300476 300479 300481 300483 300489 300490 300491 300493 300495 300496 300497 300500 300501 300506 300507 300508 300509 300510 300511 300512 300514 300515 300516 300517 300518 300519 300521 300522 300523 300525 300526 300527 300528 300530 300531 300532 300533 300534 300535 300536 300537 300538 300539 300540 300541 300542 300543 300544 300546 300547 300548 300551 300552 300553 300554 300555 300556 300557 300558 300559 300560 300561 300562 300563 300564 300565 300566 300567 300568 300569 300570 300571 300572 300573 300574 300575 300576 300577 300578 300579
- 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:
- Analyzer has calibration issues where curves switched from passed to failed due to system errors during aspiration. This anomaly causes erroneous results and delays if unnoticed. RLU values may be misinterpreted as valid measurements by LIS.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
DxI 9000 Access Immunoassay Analyzer C11137
Product Codes/Lot Numbers:
UDI-DI 15099590732103 Serial Numbers 300116 300124 300126 300128 300132 300136 300138 300144 300145 300148 300150 300153 300154 300155 300156 300157 300158 300161 300166 300168 300171 300174 300175 300178 300179 300182 300183 300186 300190 300191 300192 300193 300194 300198 300200 300201 300204 300205 300206 300207 300208 300209 300210 300211 300212 300213 300214 300215 300217 300218 300219 300221 300225 300226 300228 300231 300232 300234 300235 300236 300240 300242 300246 300249 300250 300252 300255 300266 300267 300270 300272 300273 300274 300275 300279 300280 300282 300283 300284 300285 300286 300288 300293 300299 300300 300306 300307 300308 300309 300312 300314 300316 300317 300318 300319 300321 300322 300323 300326 300327 300328 300329 300331 300333 300334 300336 300338 300339 300341 300346 300350 300352 300354 300355 300356 300358 300359 300360 300361 300362 300370 300372 300373 300375 300376 300378 300388 300389 300392 300393 300395 300396 300397 300398 300403 300407 300408 300409 300410 300411 300413 300414 300415 300420 300422 300423 300424 300425 300426 300427 300428 300430 300434 300438 300446 300454 300455 300457 300458 300461 300464 300467 300468 300470 300474 300475 300476 300479 300481 300483 300489 300490 300491 300493 300495 300496 300497 300500 300501 300506 300507 300508 300509 300510 300511 300512 300514 300515 300516 300517 300518 300519 300521 300522 300523 300525 300526 300527 300528 300530 300531 300532 300533 300534 300535 300536 300537 300538 300539 300540 300541 300542 300543 300544 300546 300547 300548 300551 300552 300553 300554 300555 300556 300557 300558 300559 300560 300561 300562 300563 300564 300565 300566 300567 300568 300569 300570 300571 300572 300573 300574 300575 300576 300577 300578 300579
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1996-2025
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.
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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.