Recall archive
73 recalls · page 3 of 4
Reported Oct 18, 2017
ARCHITECT c4000 Cuvette Segment, List number 02P75-01. The firm name on the label is Abbott Laboratories, Abbott Park,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Abbott Laboratories, Inc.
Matched: Brand · Product · Product details — There is a potential to generate falsely-depressed patient results in the cuvettes adjacent to the detached segment post for any assay run on the…
FDA (openFDA device enforcement)
Reported Jun 28, 2017
ARCHITECT SHBG Reagent The ARCHITECT SHBG assay is a chemiluminescent microparticle immunoassay (CMIA) for the…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Abbott Laboratories
Matched: Brand — Firm has identified that ARCHITECT SHBG results generated with the Potassium EDTA specimen tube type may demonstrate a negative shift relative to…
FDA (openFDA device enforcement)
Reported Mar 15, 2017
CELL-DYN Ruby System: List Number: 08H6701; Hematology: The CELL-DYN Ruby System is a multi-parameter automated…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Abbott Laboratories
Matched: Brand · Product details — The Pump Relay Printed Circuit Board Assembly (PCBA) used in the CELL-DYN Ruby instrument may prematurely fail and lead to instrument stoppage
FDA (openFDA device enforcement)
Reported Nov 16, 2016
ARCHITECT Lactic Acid Part # 09D891T21 The Lactic Acid assay is used for the quantitation of lactic acid in human…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Abbott Laboratories
Matched: Brand · Reason for recall — Abbott has identified negative interference from the drug N-Acetyl Cysteine (NAC) with the ARCHITECT Lactic Acid reagent (LN 9D89-21).
FDA (openFDA device enforcement)
Reported Jun 8, 2016
The ARCHITECT Estradiol Kit Intended to measure estradiol, an estrogenic steroid, in plasma.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Abbott Laboratories
Matched: Brand — Interaction of Fulvestrant with the ARCHITECT Estradiol assay, leading to falsely elevated estradiol results in patients treated with Fulvestrant.
FDA (openFDA device enforcement)
Reported Apr 27, 2016
CELL-DYN Emerald Cleaner, product number 09H46-02. 960mL. IVD; Hematology: The CELL-DYN Emerald Cleaner is designed for…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Abbott Laboratories
Matched: Brand · Product details — Three lots of CELL-DYN Emerald Cleaner may have occurrences where the analyzer generates Quality Control Out of Range Low for parameters RBC and PLT.
FDA (openFDA device enforcement)
Reported Nov 4, 2015
ARCHITECT i2000SR System The Abbott ARCHITECT System is intended for In Vitro diagnostic use only. The ARCHITECT system…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Abbott Laboratories, Inc.
Matched: Brand · Product · Product details — Incorrect tubing.
FDA (openFDA device enforcement)
Reported Jul 29, 2015
ARCHITECT c8000 System List Number 01G06-98 Product Usage: The Abbott ARCHITECT cSystem is intended for In Vitro…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Abbott Laboratories
Matched: Brand · Product · Product details — The ARCHITECT c8000 instrument contains tubing that does not meet specifications and has the potential to leak.
FDA (openFDA device enforcement)
Reported Jul 8, 2015
ICT Serum Calibrator REF 146-03. For use in the calibration of the serum Sodium, Potassium, and Chloride assays.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Abbott Laboratories
Matched: Brand · Reason for recall — ICT Serum Calibrator may generate lower than expected Potassium Quality Control (QC) and patient results on the Abbott Architect cSystem.
FDA (openFDA device enforcement)
Reported Jun 17, 2015
Alkaline Wash, List number 9D31-20, a cleaning solution used by the Abbott Architect analyzers. It is supplied in 500…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Abbott Laboratories
Matched: Brand · Product · Product details — The product is leaking from the cap and crystallization was noted as present around the cap.
FDA (openFDA device enforcement)
Reported Mar 18, 2015
Similac¿ Advance Complete Nutrition Infant Formula with Iron, 1.45lb plastic container.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Abbott Laboratories
Matched: Brand — The firm received three consumer calls of product with Chinese labeling. After an internal investigation, the firm discovered that product…
FDA (openFDA food enforcement)
Reported Nov 5, 2014
Lipase Reagent, 7D80. Used to measure lipase in human serum on the Architect system.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Abbott Laboratories, Inc.
Matched: Brand — Package inserts have incorrect SmartWash parameters for Triglyceride.
FDA (openFDA device enforcement)
Reported Nov 5, 2014
HbA1c Calibrators LN 4P52-02 consists of: 4P52-02 Hemoglobin A1c 1 x 1.6 mL and 1 x 1.6 mL. A1c Calibrators…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Abbott Laboratories
Matched: Brand — HbA1c Calibrators LN 4P52-02, lot 45063UQ12 may contain a value sheet for a different HbA1c calibrator lot. If calibrator lot 45063UQ12 is used in…
FDA (openFDA device enforcement)
Reported Jun 4, 2014
ARCHITECT Intact PTH Calibrators consists of 6 bottles (4.0 mL each). Calibrator A contains Bis Tris Propane buffer…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Abbott Laboratories
Matched: Brand · Reason for recall — Abbott has confirmed that a performance shift in the ARCHITECT Intact PTH assay has the potential to generate falsely elevated results on patient…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Feb 26, 2014
Similac Human Milk Fortifier Powder, .9 g packets. Label reads in part, "ADDITIONAL IRON MAY BE NECESSARY ADD ONLY TO…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Abbott Nutrition
Matched: Brand · Product details · Reason for recall — Abbott Nutrition (AN) recalled this product from the Canadian market because some of the packets may have an incomplete seal which could allow air to…
FDA (openFDA food enforcement)
Reported Oct 23, 2013
Clinical Chemistry Phosphorus Reagent The Phosphorus assay is used for the quantitation of phosphorus in human serum,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Abbott Laboratories, Inc.
Matched: Brand — Reagent lots 64736UN12, 03991UN13, 51611UN13, 74805UN12, and 03992UN13 have incorrect expiration dates assigned by Supplier.
FDA (openFDA device enforcement)
Reported Oct 2, 2013
DRI Cocaine Metabolite Assay, labeled as Multigent Cocaine Assay for Abbott Laboratories. 100 ml, IVD Mfg by:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Microgenics Corp.
Matched: Product · Product details — Surveillance of reagent stability for specific lots of DRI Cocaine Metabolite Reagent show an unexpected decreasing change in the reaction rate,…
FDA (openFDA device enforcement)
Reported Aug 28, 2013
Mavik¿ trandolapril tablets 4mg, 100 count bottle, Rx only, Manufactured by Halo Pharmaceutical Inc., Whippany, NJ for…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.AbbVie Inc.
Matched: Product details — Labeling: Incorrect Package Insert; product packaged with outdated version of the insert
FDA (openFDA drug enforcement)
Reported Apr 24, 2013
Clinical Chemistry Phenobarbital, list number 1E08
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Abbott Laboratories, Inc.
Matched: Brand · Reason for recall — Abbott Diagnostics is recalling Clinical Chemistry Phenobarbital reagent lots 62299UN12 and 85773UN12 due to imprecision issues which increase with…
FDA (openFDA device enforcement)
Reported Apr 3, 2013
ARCHITECT HBsAg Qualitative Assay, List Number 4P53 and ARCHITECT HBsAg Qualitative Confirmatory Assay, List Number…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Abbott Laboratories, Inc.
Matched: Brand · Reason for recall — Abbott has identified that assay files for the ARCHITECT HBsAg Qualitative and HBsAg Qualitative Confirmatory assays (LNs 4P53 and 4P54) on the…
FDA (openFDA device enforcement)
Reported Jan 30, 2013
Abbott Laboratories, ARCHITECT 25-OH Vitamin D Reagent Kit, 03L52-25 (ROW) and 03L52-27 (U.S.) (1 x 100 tests),…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Abbott Laboratories
Matched: Brand · Product · Product details — The Architect 25-OH Vitamin D assay has the potential to generate falsely elevated or falsely depressed results when used with certain lots of…
FDA (openFDA device enforcement)
Reported Jan 9, 2013
Synthroid (Levothyroxine Sodium) tablets, 150 mcg (0.15 mg), 90 tablets per bottle, Rx Only, NDC 0074-7069-90; ABBOTT…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Abbott Laboratories
Matched: Brand · Product · Product details — Labeling: Error on Declared Strength. Product labeled to contain 150 mcg tablets actually contained 75 mcg tablets.
FDA (openFDA drug enforcement)
Reported Oct 3, 2012
Synthroid (levothyroxine sodium) Tablets USP, 50 mcg, Rx Only, 90-Count Bottle, Abbott Laboratories, North Chicago, IL…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Abbott Laboratories
Matched: Brand · Product · Product details — Defective Container: A number of Synthroid bottles have a localized thin wall defect on the bottom which may potentially impact the stability of the…
2 more products in this recall
FDA (openFDA drug enforcement)
Reported Jul 4, 2012
ARCHITECT CA 19-9XR Reagent Kit; ARCHITECT CA 19-9 Reagent Kit, list 291-20 (4 x 100 tests), 2K91-25 and 2K91-27 (1 x…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Abbott Laboratories
Matched: Brand · Reason for recall — The six ARCHITECT CA 19-9XR reagent lots are demonstrating a shift up in patient results. The Abbott Controls however do not detect the upward shift…
FDA (openFDA device enforcement)
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