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FDAFDA · Food and drugs·Recall number Z-0682-2024

ARCHITECT c4000 Processing Module REF: 02P24-01 02P24-02 02P24-40 01R24-56 01R25-56 The Abbott ARCHITECT c4000 Processing Module is designed to perform automated chemistry tests, utilizing photometry and potentiometric technology.

Published January 17, 2024 · Recall initiated: October 19, 2023

Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

The devices contain a dry natural rubber (latex) subcomponent, which are not labeled as containing dry natural rubber(latex).

What to do

Voluntary: Firm initiated · Letter

Recall details

Manufacturer
Abbott Laboratories
Distributor
U.S.: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV O.U.S.: Brazil
Lot
List Number: 02P24-01 Serial Numbers / UDI Codes: C400911 (01)00380740003746(21)C400911 C402913 (01)00380740003746(21)C402913 C460004 (01)00380740003746(21)C460004 C460033 (01)00380740003746(21)C460033 C460055 (01)00380740003746(21)C460055 C460066 (01)00380740003746(21)C460066 C460082 (01)00380740003746(21)C460082 C460158 (01)00380740003746(21)C460158 C460200 (01)00380740003746(21)C460200 C460375 (01)00380740003746(21)C460375 C460385 (01)00380740003746(21)C460385 C460396 (01)00380740003746(21)C460396 C460397 (01)00380740003746(21)C460397 C460408 (01)00380740003746(21)C460408 C460410 (01)00380740003746(21)C460410 C460422 (01)00380740003746(21)C460422 C460435 (01)00380740003746(21)C460435 C460439 (01)00380740003746(21)C460439 C460523 (01)00380740003746(21)C460523 C460532 (01)00380740003746(21)C460532 C460588 (01)00380740003746(21)C460588 C460728 (01)00380740003746(21)C460728 C460767 (01)00380740003746(21)C460767 C460797 (01)00380740003746(21)C460797 C460798 (01)00380740003746(21)C460798 C460800 (01)00380740003746(21)C460800 C460826 (01)00380740003746(21)C460826 C460827 (01)00380740003746(21)C460827 C460830 (01)00380740003746(21)C460830 C460832 (01)00380740003746(21)C460832 C460833 (01)00380740003746(21)C460833 C460834 (01)00380740003746(21)C460834 C460846 (01)00380740003746(21)C460846 C460849 (01)00380740003746(21)C460849 C460857 (01)00380740003746(21)C460857 C460868 (01)00380740003746(21)C460868 C460875 (01)00380740003746(21)C460875 C460886 (01)00380740003746(21)C460886 C460927 (01)00380740003746(21)C460927 C460928 (01)00380740003746(21)C460928 C460939 (01)00380740003746(21)C460939 C460958 (01)00380740003746(21)C460958 C460993 (01)00380740003746(21)C460993 C461042 (01)00380740003746(21)C461042 C461092 (01)00380740003746(21)C461092 C461093 (01)00380740003746(21)C461093 C461100 (01)00380740003746(21)C461100 C461105 (01)00380740003746(21)C461105 C461112 (01)00380740003746(21)C461112 C461122 (01)00380740003746(21)C461122 C461124 (01)00380740003746(21)C461124 C461129 (01)00380740003746(21)C461129 C461130 (01)00380740003746(21)C461130 C461132 (01)00380740003746(21)C461132 C461133 (01)00380740003746(21)C461133 C461138 (01)00380740003746(21)C461138 C461148 (01)00380740003746(21)C461148 C461150 (01)00380740003746(21)C461150 C461151 (01)00380740003746(21)C461151 C461155 (01)00380740003746(21)C461155 C461172 (01)00380740003746(21)C461172 C461173 (01)00380740003746(21)C461173 C461175 (01)00380740003746(21)C461175 C461176 (01)00380740003746(21)C461176 C461192 (01)00380740003746(21)C461192 C461195 (01)00380740003746(21)C461195 C461208 (01)00380740003746(21)C461208 C461212 (01)00380740003746(21)C461212 C461220 (01)00380740003746(21)C461220 C461222 (01)00380740003746(21)C461222 C461247 (01)00380740003746(21)C461247 C461250 (01)00380740003746(21)C461250 C461271 (01)00380740003746(21)C461271 C461272 (01)00380740003746(21)C461272 C461408 (01)00380740003746(21)C461408 C461412 (01)00380740003746(21)C461412 C461413 (01)00380740003746(21)C461413 C461414 (01)00380740003746(21)C461414 C461420 (01)00380740003746(21)C461420 C461425 (01)00380740003746(21)C461425 C461446 (01)00380740003746(21)C461446 C461451 (01)00380740003746(21)C461451 C461453 (01)00380740003746(21)C461453 C461455 (01)00380740003746(21)C461455 C461457 (01)00380740003746(21)C461457 C461459 (01)00380740003746(21)C461459 C461462 (01)00380740003746(21)C461462 C461473 (01)00380740003746(21)C461473 C461474 (01)00380740003746(21)C461474 C461475 (01)00380740003746(21)C461475 C461476 (01)00380740003746(21)C461476 C461477 (01)00380740003746(21)C461477 C461491 (01)00380740003746(21)C461491 C461492 (01)00380740003746(21)C461492 C461495 (01)00380740003746(21)C461495 C461496 (01)00380740003746(21)C461496 C461497 (01)00380740003746(21)C461497 C461498 (01)00380740003746(21)C461498 C461528 (01)00380740003746(21)C461528 C461553 (01)00380740003746(21)C461553 C461554 (01)00380740003746(21)C461554 C461555 (01)00380740003746(21)C461555 C461562 (01)00380740003746(21)C461562 C461563 (01)00380740003746(21)C46156
Risk classification
Class II
Area (FDA)
device
Country
United States

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