Drugs & medicalClass II

Abbott Laboratories recalls Alinity ci-series System Control Module (SCM), REF: 03R70-01, 03R70-20

Abbott Laboratories is recalling their Alinity ci-series System Control Module, a chemistry/immunoassay anayzer, by correction. The reason for the recall is potential performance issues found in the Alinity ci-series…

Read the official notice →
Date
2025-12-24
Country
United States
Brand
Abbott Laboratories
Product
Alinity ci-series System Control Module (SCM), REF: 03R70-01, 03R70-20
Classification
Class II
Units
Worldwide distribution: US (nationwide) to states of: AK, AL, AR, AZ, CA, CO,…
Category
Drugs & medical
Source
FDA · Device

Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer

What to do

  1. Check the product name, strength and lot number against the official notice.
  2. Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
  3. Ask the pharmacy or supplier about a replacement or refund.

General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.

More Abbott Laboratories recalls

  1. 2025-11-19
  2. US
    Drugs & medicalClass II

    Abbott Laboratories recalls Brand Name: Alinity hq Analyzer Product Name: Alinity hq Analyzer Model/Catalog Number: 09P68-01 Software Version: 5.0 to 5.10.1 for OUS,…

    Software issue for hq analyzer results in system not visibly applying appropriate flagging to results when saturation is present which may result in incorrect results.

    FDA · DeviceAbbott LaboratoriesWorldwide distribution: US (nationwide) to states of: AL, CA, CO, FL, IN, MN,…Official notice →
  3. 2025-04-30
  4. US
    Drugs & medicalClass II

    Abbott Laboratories recalls Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-01 Software Version: All software versions Product…

    When expired reagents are scanned or manually entered, the system will change the expiration date to current or future date without notifying user that an expired reagent is being used. Use of expired reagents is…

    FDA · DeviceAbbott LaboratoriesWorldwide distribution: US (nationwide) to the following states: AR, AZ, CA,…Official notice →
  5. 2024-08-28
  6. US
    Drugs & medicalClass II

    Abbott Laboratories recalls Alinity hq Analyzer, REF: 09P68-01

    1)If Complete Blood Count with differential and reticulocyte(CBC+Diff+Retic) sample is run, then immediately following on same rack CBC+Diff sample is run, then falsely low red blood cell count may occur, generating…

    FDA · DeviceAbbott LaboratoriesWorldwide - US Nationwide distribution in the states of NY, OK, NC and the…Official notice →
  7. 2024-04-10
  8. US
    Drugs & medicalClass II

    Abbott Laboratories recalls ARCHITECT STAT Myoglobin Reagent Kit, LN 2K43-25 and 2K43-20.

    The reason for the recall is the failure of calibration and quality controls due to a manufacturing issue of microparticles not meeting labeled claim. This may lead to incorrect myoglobin results and delayed diagnosis…

    FDA · DeviceAbbott LaboratoriesWorldwide - US Nationwide distribution in the states of AL, AR, AZ, CA, FL,…Official notice →
  9. 2024-01-17
  10. US
    Drugs & medicalClass II

    Abbott Laboratories recalls Alinity i Processing Module REF 03R65-01 The Alinity i Processing Module is a fully automated immunoassay analyzer allowing random and…

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

    FDA · DeviceAbbott LaboratoriesU.S.: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA,…Official notice →
  11. 2024-01-03
  12. US
    Drugs & medicalClass II

    Abbott Laboratories recalls Alinity ci-series System Control Module, REF: 03R70-01

    There are potential performance issues found in the Alinity ci-series System software versions 3.4.0 and lower, including: 1) SCC Reagent load error during daily maintenance; 2) Sample Laboratory Report error; 3)…

    FDA · DeviceAbbott LaboratoriesUS: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA,…Official notice →
All 21 Abbott Laboratories recalls →

Other drugs & medical recalls in the United States

  1. 2025-12-31
  2. US
    Drugs & medicalClass I

    Draeger, Inc. recalls Draeger Vapor 2000. Unheated, calibrated anesthetic vaporizer.

    A certain component of affected devices was not delivered within specification and contained impurities.

    FDA · DeviceDraeger, Inc.Worldwide - US Nationwide distribution in the states of AK, CA, FL, IA, KS,…Official notice →
  3. US
    Drugs & medicalClass II

    AGFA Healthcare Corp. recalls Brand name: AGFA Digital Radiography X- Ray system DR 800 with MUSICA Dynamic Common Name: DR 800

    It is possible to exceed the maximum allowed Air Kerma rate (AKR) of 88mGy/min for pulsed fluoro exams. This can happen in case the framerate is increased on the NX workstation when ABS is not enabled.

    FDA · DeviceAGFA Healthcare Corp.U.S. Nationwide distribution.Official notice →
  4. US
    Drugs & medicalClass II

    Merck Sharp & Dohme LLC recalls Merck Emend (aprepitant) for oral suspension, 125 mg, Single-Dose Kit, Rx Only, Manufactured for: Merck Sharpe & Dohme LLC, Rahway, NJ…

    Presence of particulate matter: potential presence of metal particulates in the product.

    FDA · DrugMerck Sharp & Dohme LLCNationwide in the USAOfficial notice →
  5. 2025-12-24
  6. US
    Drugs & medicalClass II

    Cepheid recalls Brand Name: Xpert¿ BCR-ABL Ultra Model/Catalog Number: GXBCRABL-10

    Invitro diagnostic test kits with specimens that have elevated white blood cell count (>30,000 cell) may cause inaccurate results.

    FDA · DeviceCepheidUS: AL AR AZ CA CO FL GA IA IL KS KY LA MD ME MI MN MO NC NE NH NJ NY OH PA RI…Official notice →
  7. US
    Drugs & medicalClass II

    Medtronic MiniMed, Inc. recalls InPen App, Model/CFN Number: MMT-8061 (Android Users)

    When app is uninstalled and reinstalled, insulin pen software issue causes Choose Notification Style Screen to not show during setup so users can't choose to allow notifications to override phone settings when on…

    FDA · DeviceMedtronic MiniMed, Inc.US: IL, AZ, MN, NE, KS, TN, CA, FL, TX, WA, MO, NC, NY, WI, IN, ME, CT, RI,…Official notice →
  8. US
    Drugs & medicalClass II

    Smith & Nephew, Inc. recalls BIOSURE HA SCREW, 6MM x 20 MM. Threaded metallic bone fixation fastener.

    Removal of affected lot of screws due to labeling error.

    FDA · DeviceSmith & Nephew, Inc.US (nationwide) distribution to states of : AL, CA, CO, FL, IA, IL, KY, MN,…Official notice →
See all drugs & medical recalls →