Recall Z-0681-2024
Abbott Laboratories · initiated October 19, 2023
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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).
Codes / lots: 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)00380740137380(21)AC01522 AC01523 (01)00380740137380(21)AC01523 AC01553 (01)00380740137380(21)AC01553 AC01554 (01)00380740137380(21)AC01554 AC01561 (01)00380740137380(21)AC01561 AC01566…
Reason for recall
The devices contain a dry natural rubber (latex) subcomponent, which are not labeled as containing dry natural rubber(latex).
FDA-determined cause: Under Investigation by firm
Action taken
On 10/19/2023, the firm sent an "Urgent Medical Device Correction" Letter via FedEx priority overnight express to customers informing them that Abbott has determined that, A labeling update is required for the products listed above to meet US regulatory requirement 21 CFR 801.437 (User labeling for devices that contain natural rubber) and Brazilian requirement RDC 37/2015 (medical devices and IVDs to include in the label a Standardized Latex Warning in Portuguese CONTAIN NATURAL LATEX. MAY CAUSE ALLERGIES ). These Abbott products include internal hardware parts and/or subassemblies that contain dry natural rubber (latex) which may cause allergic reactions, but do not include the required precautionary label. Additionally, the Alinity s System Solid Waste Container Rubber Band (LN 04U97-01), used to secure the biohazard bag to the solid waste container, contains dry natural rubber (latex). Customer are instructed to: 1) Follow good laboratory practice by wearing impervious gloves and other personal protective equipment when working on the above listed Abbott product(s). 2) If you have forwarded the product(s) listed above to other laboratories, please inform them of this Product Correction and provide a copy of this letter. 3) Please retain this letter for your laboratory records. A precautionary label will be applied to the affected products. An Abbott representative will schedule a service visit when the instrument label is available for application. For questions or concerns, contact Customer Service at 1-877-4ABBOTT (24 hr/7 days a week).
Details
- Recall number
- Z-0681-2024
- Initiated
- October 19, 2023
- Posted by FDA
- January 9, 2024
- Product code
- JJE – Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
- Quantity
- 1,127 systems
- Distribution
- 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
- Recalling firm
- Abbott Laboratories, Irving, TX
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0680-2024 Class II | Alinity i Processing Module REF 03R65-01 The Alinity i Processing Module is a fully…The devices contain a dry natural rubber (latex) subcomponent, which are not labeled as containing dry… | 10/19/2023Open, Classified |
| Z-0682-2024 Class II | ARCHITECT c4000 Processing Module REF: 02P24-01 02P24-02 02P24-40 01R24-56 01R25-56 The…The devices contain a dry natural rubber (latex) subcomponent, which are not labeled as containing dry… | 10/19/2023Open, Classified |