FDA Device recall Z-0681-2024
Alinity c Processing Module REF 03R67-01 The Alinity c Processing Module is a fully automated chemistry analyzer allowing random and contin…
- FDA Device
- Class II
- ongoing
- Published 2024-01-17
On 2024-01-17 the FDA classified a Class II recall of Alinity c Processing Module REF 03R67-01 The Alinity c Processing Module is a fully automated chemistry analyzer allowing random and contin… by Abbott Laboratories, citing the devices contain a dry natural rubber (latex) subcomponent, which are not labeled as containing dry natural rubber(latex).
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0681-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-10-19 |
| Published | 2024-01-17 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Abbott Laboratories |
| Distribution | 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, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV |
Product
Alinity c Processing Module REF 03R67-01 The Alinity c Processing Module is a fully automated chemistry analyzer allowing random and continuous access, as well as priority and automated retest processing using photometric and potentiometric detection technology. The Alinity c Processing Module uses photometric detection technology to measure sample absorbance for the quantification of analyte concentration and uses potentiometric detection technology to measure the electrical potential in a sample. In addition, the Alinity c Processing Module uses an integrated chip technology (ICT) module to measure potentiometric assays (electrolytes).
Reason
The devices contain a dry natural rubber (latex) subcomponent, which are not labeled as containing dry natural rubber(latex).
Identifiers
| code_info | List Number: 03R67-01 Serial Numbers / UDI-DI codes (U.S. systems): AC01225 (01)00380740137380(21)AC01225 AC01226 (01)0…List Number: 03R67-01 Serial Numbers / UDI-DI codes (U.S. systems): AC01225 (01)00380740137380(21)AC01225 AC01226 (01)00380740137380(21)AC01226 AC01256 (01)00380740137380(21)AC01256 AC01257 (01)00380740137380(21)AC01257 AC01263 (01)00380740137380(21)AC01263 AC01264 (01)00380740137380(21)AC01264 AC01273 (01)00380740137380(21)AC01273 AC01274 (01)00380740137380(21)AC01274 AC01275 (01)00380740137380(21)AC01275 AC01356 (01)00380740137380(21)AC01356 AC01357 (01)00380740137380(21)AC01357 AC01358 (01)00380740137380(21)AC01358 AC01503 (01)00380740137380(21)AC01503 AC01504 (01)00380740137380(21)AC01504 AC01505 (01)00380740137380(21)AC01505 AC01506 (01)00380740137380(21)AC01506 AC01507 (01)00380740137380(21)AC01507 AC01508 (01)00380740137380(21)AC01508 AC01509 (01)00380740137380(21)AC01509 AC01510 (01)00380740137380(21)AC01510 AC01512 (01)00380740137380(21)AC01512 AC01513 (01)00380740137380(21)AC01513 AC01518 (01)00380740137380(21)AC01518 AC01521 (01)00380740137380(21)AC01521 AC01522 (01)00380740 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0681-2024%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.