Abbott Laboratories recalls
21 official recalls and safety alerts involving Abbott Laboratories since 2021-12, from FDA · Device, FDA · Food. Newest first. Check the official notice for exact models and batch codes.
This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Abbott Laboratories or the relevant agency.
- 2025-12-24
USAbbott 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…
FDA · DeviceAbbott LaboratoriesWorldwide distribution: US (nationwide) to states of: AK, AL, AR, AZ, CA, CO,…Official notice →- 2025-11-19
- US
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 → - 2025-04-30
- US
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 → - 2024-08-28
- US
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 → - 2024-04-10
- US
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 → - 2024-01-17
- US
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 → - 2024-01-03
- US
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 → - 2023-12-27
- US
Abbott Laboratories recalls Abbott CELL-DYN Ruby, Model CD-Ruby, List number 08H67-01, and Abbott CELL-DYN Sapphire, Model CD Sapphire, list number 08H00-01.…
The devices contain a dry natural rubber (latex) subcomponent, which are not labeled as containing dry natural rubber(latex).
FDA · DeviceAbbott LaboratoriesDistribution was made to AL, AR, AZ, CA, CO, FL, GA, IA, IL, IN, KS, KY, LA,…Official notice → - 2023-11-15
- US
Abbott Laboratories recalls Similac Probiotic Tri-Blend - 0.017oz (0.50g) packaged in foil packets. 50 foil packets per carton - 3 cartons per case.
Marketed towards preterm infants without approval as a new drug or licensed biologic, as well as unsafe food additive
FDA · FoodAbbott LaboratoriesAlabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida,…Official notice → - 2023-04-19
- US
Abbott Laboratories recalls Zone Perfect Fudge Graham bar 50g bars packaged in foil wrapped- 12 bars individually wrapped per cardboard carton
Potential of foreign material (hard plastic) within product
FDA · FoodAbbott LaboratoriesAL, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO,…Official notice → - 2023-01-25
- US
Abbott Laboratories recalls Alinity Reaction Vessels, REF: 06P1401, for use with Alinity i Systems; ARCHITECT Reaction Vessels
Reaction vessels may contain a potential contaminant that could affect their optical performance.
FDA · DeviceAbbott LaboratoriesUS Distribution: IL, MN, MO, NC, ND, NJ, NY, OK, SC, TX, WVOfficial notice → - 2022-11-23
- US
Abbott Laboratories recalls Similac 360 Total Care 2 fl oz reclose able plastic bottle Packaged as: 6 count carton, 12 count carton, 48 count case
Compromised seal integrity which could lead to spoilage
FDA · FoodAbbott LaboratoriesDomestic: Alaska, Alabama, Arizona, California, Colorado, Connecticut,…Official notice → - 2022-09-07
- US
Abbott Laboratories recalls ARCHITECT STAT Troponin-I Reagent Kit, REF 2K41-27
One lot of reagent was manufactured with insufficient quantities of the heterophilic blocking agents in the conjugate component.
- 2022-08-31
- US
Abbott Laboratories recalls Abbott Jevity Complete, Balanced Nutrition with Fiber Ready to Hang enteral feeding container 1.5 Cal (for tube feeding) 1000 mL 8-33.8 FL…
Potential leaking/pinholes in bottle
FDA · FoodAbbott LaboratoriesDistributed to consignees in MD, NY, AL, FL, MA, NJ, and MIOfficial notice → - 2022-08-03
- US
Abbott Laboratories recalls REF: 08P4377, Alinity c Hemoglobin Reagent Kit, IVD, CE, R1 5 x 46.0 mL, R2 5 x 18.3 mL, A1cDL 5 x 67.6 mL
There is a potential for falsely elevated Hemoglobin %A1c and Hemoglobin A1c results to be generated using the ARCHITECT and Alinity c Hemoglobin A1c assay.
FDA · DeviceAbbott LaboratoriesUS: AK AL AR AZ CA CO CT FL GA IA ID IL IN KS KY LA MA MD MI MN MO MS MT NC ND…Official notice → - 2022-06-29
- US
Abbott Laboratories recalls Pedialyte with Immune Support***+Zinc/Selenium & Magnesium***Peach Mango Natural & Artificial Flavor, 33.8 FL OZ (1.05 QT)…
These products are being recalled due to the potential of leakage from the 1L container.
FDA · FoodAbbott LaboratoriesAL, AR, AZ, CA, CO, DE, FL, GA, IA, IL, IN, KS, KY, LA, MI, MO, MS, NC, NH,…Official notice → - 2022-06-22
- US
Abbott Laboratories recalls Pedialyte***Replaces Electrolytes***Great for Kids and Adults***Strawberry Lemonade Natural Flavor with Other Natural Flavor*** 6 0.6 OZ…
The third party contract manufacturer used a dextrose ingredient derived from wheat in one lot of the Strawberry Lemonade powder, which is not declared on the label.
- 2022-04-13
- US
Abbott Laboratories recalls ARCHITECT STAT Myoglobin Calibrators, RES 2K43-01 The ARCHITECT STAT Myoglobin Calibrators are for the calibration of the ARCHITECT…
This calibrator lot did not meet acceptance criteria during ongoing stability testing. When a calibration is performed with this lot, controls may exceed the specified range in the Instructions for Use (IFU).
FDA · DeviceAbbott LaboratoriesWorldwide Distribution: US (nationwide) and OUS (foreign) including countries…Official notice → - 2022-03-23
- US
Abbott Laboratories, Inc recalls Alinity s System software version2.8.0, REF LN 06P16-01, IVD, OEI: (01)00380740138479 The Alinity s System is intended for In Vitro…
Software error associated with the immunoassay analyzer wash cycle which is using 1 mL of wash buffer instead of the intended 3 mL of wash buffer to wash the exterior of the probe.
FDA · DeviceAbbott Laboratories, IncWorldwide distribution: US (nationwide) including states of: AL, CA, GA, IL,…Official notice → - 2022-03-16
- US
Abbott Laboratories recalls Abbott Similac Advance Infant Formula with Iron 12.4oz. can, 23.2oz. plastic jar, 20.6oz. plastic jar. 6 units per case. Abbott Similac…
Consumer complaints related to Cronobacter sakazakii or Salmonella Newport in infants and evidence of Cronobacter sakazakii in the manufacturing facility where the product had been produced
- 2021-12-01
- US
Abbott Laboratories recalls ARCHITECT i1000SR REF 01L86-01/1L86 and 1L87; ARCHITECT i2000SR REF 03M74-02/3M74; ARCHITECT i2000 REF 08C89-01/1G17 and 8C89
Twelve software-related issues affecting software version 9.41 and earlier were identified. The issues include bypassing error codes, incorrect calibration, loss of module communication leading to overfilling wash…
FDA · DeviceAbbott LaboratoriesU.S.: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY,…Official notice →