Recall archive
73 recalls · page 1 of 4
Reported Dec 24, 2025
Alinity ci-series System Control Module (SCM), REF: 03R70-01, 03R70-20
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Abbott Laboratories
Matched: Brand · Reason for recall — Abbott Laboratories is recalling their Alinity ci-series System Control Module, a chemistry/immunoassay anayzer, by correction. The reason for the…
FDA (openFDA device enforcement)
Reported Nov 19, 2025
Brand Name: Alinity hq Analyzer Product Name: Alinity hq Analyzer Model/Catalog Number: 09P68-01 Software Version: 5.0…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Abbott Laboratories
Matched: Brand — Software issue for hq analyzer results in system not visibly applying appropriate flagging to results when saturation is present which may result in…
FDA (openFDA device enforcement)
Reported Apr 30, 2025
Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog Number: 08H67-01 Software Version: All software…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Abbott Laboratories
Matched: Brand — When expired reagents are scanned or manually entered, the system will change the expiration date to current or future date without notifying user…
4 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 28, 2024
Alinity hq Analyzer, REF: 09P68-01
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Abbott Laboratories
Matched: Brand — 1)If Complete Blood Count with differential and reticulocyte(CBC+Diff+Retic) sample is run, then immediately following on same rack CBC+Diff sample…
FDA (openFDA device enforcement)
Reported Apr 10, 2024
ARCHITECT STAT Myoglobin Reagent Kit, LN 2K43-25 and 2K43-20.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Abbott Laboratories
Matched: Brand — The reason for the recall is the failure of calibration and quality controls due to a manufacturing issue of microparticles not meeting labeled…
FDA (openFDA device enforcement)
Reported Jan 17, 2024
Alinity i Processing Module REF 03R65-01 The Alinity i Processing Module is a fully automated immunoassay analyzer…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Abbott Laboratories
Matched: Brand — The devices contain a dry natural rubber (latex) subcomponent, which are not labeled as containing dry natural rubber(latex).
2 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 3, 2024
Alinity ci-series System Control Module, REF: 03R70-01
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Abbott Laboratories
Matched: Brand · Reason for recall — 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…
FDA (openFDA device enforcement)
Reported Dec 27, 2023
Abbott CELL-DYN Ruby, Model CD-Ruby, List number 08H67-01, and Abbott CELL-DYN Sapphire, Model CD Sapphire, list number…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Abbott Laboratories
Matched: Brand · Product · Product details — The devices contain a dry natural rubber (latex) subcomponent, which are not labeled as containing dry natural rubber(latex).
FDA (openFDA device enforcement)
Reported Nov 15, 2023
Similac Probiotic Tri-Blend - 0.017oz (0.50g) packaged in foil packets. 50 foil packets per carton - 3 cartons per case.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Abbott Laboratories
Matched: Brand — Marketed towards preterm infants without approval as a new drug or licensed biologic, as well as unsafe food additive
FDA (openFDA food enforcement)
Reported Apr 19, 2023
Zone Perfect Fudge Graham bar 50g bars packaged in foil wrapped- 12 bars individually wrapped per cardboard carton
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Abbott Laboratories
Matched: Brand — Potential of foreign material (hard plastic) within product
FDA (openFDA food enforcement)
Reported Jan 25, 2023
Alinity Reaction Vessels, REF: 06P1401, for use with Alinity i Systems; ARCHITECT Reaction Vessels
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Abbott Laboratories
Matched: Brand — Reaction vessels may contain a potential contaminant that could affect their optical performance.
FDA (openFDA device enforcement)
Reported Nov 23, 2022
Pedialyte Unflavored Electrolyte Solution 2 fl oz plastic reclosable bottle 12-4 packs in a case
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Abbott Laboratories
Matched: Brand — Compromised seal integrity which could lead to spoilage
11 more products in this recall
FDA (openFDA food enforcement)
Reported Sep 7, 2022
ARCHITECT STAT Troponin-I Reagent Kit, REF 2K41-27
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Abbott Laboratories
Matched: Brand — One lot of reagent was manufactured with insufficient quantities of the heterophilic blocking agents in the conjugate component.
FDA (openFDA device enforcement)
Reported Sep 7, 2022
Glucerna original Rich Chocolate Shake, 8 FL OZ (237 mL). Delicious Snack or Small Meal Replacement. UPC 0 70074-68565…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Lyons Magnus, Inc.
Matched: Product details — Findings and potential for Cronobacter sakazakii and Clostridium botulinum.
76 more products in this recall
FDA (openFDA food enforcement)
Reported Aug 31, 2022
Abbott Jevity Complete, Balanced Nutrition with Fiber Ready to Hang enteral feeding container 1.5 Cal (for tube…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Abbott Laboratories
Matched: Brand · Product · Product details — Potential leaking/pinholes in bottle
FDA (openFDA food enforcement)
Reported Aug 3, 2022
REF: 4P52-20 Hemoglobin A1c for use with Architect, IVD, CE, R1 1 x 52 mL, R2 1 x 20 mL, A1cDL 2 x 35 mL
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Abbott Laboratories
Matched: Brand — There is a potential for falsely elevated Hemoglobin %A1c and Hemoglobin A1c results to be generated using the ARCHITECT and Alinity c Hemoglobin A1c…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 29, 2022
Pedialyte with Immune Support***+Zinc/Selenium & Magnesium***Peach Mango Natural & Artificial Flavor, 33.8 FL OZ (1.05…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Abbott Laboratories
Matched: Brand · Product details — These products are being recalled due to the potential of leakage from the 1L container.
1 more product in this recall
FDA (openFDA food enforcement)
Reported Jun 22, 2022
Pedialyte***Replaces Electrolytes***Great for Kids and Adults***Strawberry Lemonade Natural Flavor with Other Natural…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Abbott Laboratories
Matched: Brand · Product details — The third party contract manufacturer used a dextrose ingredient derived from wheat in one lot of the Strawberry Lemonade powder, which is not…
FDA (openFDA food enforcement)
Reported Apr 13, 2022
ARCHITECT STAT Myoglobin Calibrators, RES 2K43-01 The ARCHITECT STAT Myoglobin Calibrators are for the calibration of…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Abbott Laboratories
Matched: Brand — This calibrator lot did not meet acceptance criteria during ongoing stability testing. When a calibration is performed with this lot, controls may…
FDA (openFDA device enforcement)
Reported Mar 23, 2022
Alinity s System software version2.8.0, REF LN 06P16-01, IVD, OEI: (01)00380740138479 The Alinity s System is intended…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Abbott Laboratories, Inc.
Matched: Brand — 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…
FDA (openFDA device enforcement)
Reported Mar 16, 2022
Abbott EleCare Infant Formula Unflavoured 400g can. 6 cans per case. Item number 5466539 Retail unit UPC 070074104591
High riskUsing this product could cause serious injury, illness or death — stop using it now.Abbott Laboratories
Matched: Brand · Product · Product details — Consumer complaints related to Cronobacter sakazakii or Salmonella Newport in infants and evidence of Cronobacter sakazakii in the manufacturing…
40 more products in this recall
FDA (openFDA food enforcement)
Reported Dec 1, 2021
ARCHITECT i1000SR REF 01L86-01/1L86 and 1L87; ARCHITECT i2000SR REF 03M74-02/3M74; ARCHITECT i2000 REF 08C89-01/1G17…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Abbott Laboratories
Matched: Brand — Twelve software-related issues affecting software version 9.41 and earlier were identified. The issues include bypassing error codes, incorrect…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Sep 22, 2021
Alinity ci-series System Control Module clinical chemistry and immunoassay analyzer for in vitro diagnostic use. Model…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Abbott Laboratories
Matched: Brand — Due to potential performance issues with software version 3.2.3 and earlier. Performance issues are: 1) There is the potential for onboard reagents…
FDA (openFDA device enforcement)
Reported Aug 18, 2021
Alinity s System REF 06P16-01. An automated immunoassay analyzer for In Vitro diagnostic use in blood donor screening,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Abbott Laboratories, Inc.
Matched: Brand · Product details — A design defect (hardware and software) allows liquid waste pressure to build up and potentially spray users/operators.
FDA (openFDA device enforcement)
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