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Ascend Laboratories, LLC

Ascend Laboratories, LLC Recalls

All product recalls associated with Ascend Laboratories, LLC.

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Recall Summary

Total Recalls

1000

Past Year

100

Class I (Serious)

Most Recent

Dec 2025

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 381–400 of 2670 recalls

Dabigatran Etexilate Capsules (Ascend Laboratories) – Impurity Levels (2023)

CGMP Deviations: Detection of N-nitroso-dabigatran (NDAB) impurity levels above the Acceptable Daily Intake Limit.

Class IIModerate

FDAMar 14, 2023Nationwide• Ascend Laboratories, LLC

BioPlex 2200 APLS IgM Pack (Bio-Rad) – Reagent Conjugate Mismatch (2023)

APLS IgM reagent kits were packaged with the incorrect conjugate, which could lead to an increase in false-positive and false-negative results.

High

FDAFeb 28, 2023Nationwide• Bio-Rad Laboratories, Inc.

Thor Motor Coach Hurricane (Thor) - Cabinet Mounting (2023)

Thor Motor Coach (TMC) is recalling certain 2018-2021 Hurricane and Windsport recreational vehicles. The driver and front passenger overhead cabinets may detach.

High

1...18 192021 22...134

Page 20 of 134Next

NHTSA

Feb 24, 2023

Nationwide

• THOR MOTOR COACH

Thor Motor Coach Palazzo (Thor) - Bracket Support (2023)

Thor Motor Coach (TMC) is recalling certain 2015-2023 Palazzo recreational vehicles. The front lower cap brackets that support the front fiberglass panel may become loose and detach from the vehicle while in motion.

Moderate

NHTSAFeb 23, 2023Nationwide• THOR MOTOR COACH

BioPlex 2200 Reagent Pack (Bio-Rad) - Result Discrepancy (2023)

Moderate

FDAFeb 21, 2023Nationwide• Bio-Rad Laboratories, Inc.

BioPlex 2200 Calibrator Set (Bio-Rad) - Result Discrepancy (2023)

Bio-Rad received four customer complaints from 11/30/2022 to 12/21/2022 on BioPlex 2200 Anti-CCP Kit (Lot 301481) stating that results were discrepant while performing lot-to-lot validation against previous lots. Internal testing at Bio-Rad has demonstrated that Lot No. 301481 exhibits a specificity of 94.5% (95% CI 91.8 96.4) whereas the IFU indicates a specificity of 97.8% (95% CI 96.1 98.8%). The reduction in specificity may lead to an increase in the number of false positivesBio-Rad received four customer complaints from 11/30/2022 to 12/21/2022 on BioPlex 2200 Anti-CCP Kit (Lot 301481) stating that results were discrepant while performing lot-to-lot validation against previous lots. Internal testing at Bio-Rad has demonstrated that Lot No. 301481 exhibits a specificity of 94.5% (95% CI 91.8 96.4) whereas the IFU indicates a specificity of 97.8% (95% CI 96.1 98.8%). The reduction in specificity may lead to an increase in the number of false positivesBio-Rad received four customer complaints from 11/30/2022 to 12/21/2022 on BioPlex 2200 Anti-CCP Kit (Lot 301481) stating that results were discrepant while performing lot-to-lot validation against previous lots. Internal testing at Bio-Rad has demonstrated that Lot No. 301481 exhibits a specificity of 94.5% (95% CI 91.8 96.4) whereas the IFU indicates a specificity of 97.8% (95% CI 96.1 98.8%). The reduction in specificity may lead to an increase in the number of false positives.There is no performance issue with the calibrator lot# 53727. They are included in the recall only because the calibrators are lot matched to the impacted reagent pack.

Low

FDAFeb 21, 2023Nationwide• Bio-Rad Laboratories, Inc.

Raystation Treatment Planning (RaySearch) - Collimator Angle (2023)

It is possible to set a non-zero collimator angle in the Virtual Simulation module. The angle will be correct in the user interface but if the plan is DICOM exported by using the VSIM Export button, the angle will not be correct in the exported RT plan. In the exported RT plan, the DICOM attribute Beam Limiting Device Angle (300A,0120) is set to zero, regardless of the selected collimator angle.

Moderate

FDAFeb 17, 2023Nationwide• RAYSEARCH LABORATORIES AB Eugeniavagen 18c Stockholm Sweden

Thor Motor Coach Scope (Thor) – Unintended Awning Extension (2023)

Thor Motor Coach (TMC) is recalling certain 2021-2023 Rize and Scope camper vans. The retractable awning may extend unintentionally during transit.

Moderate

NHTSAFeb 10, 2023Nationwide• THOR MOTOR COACH

Yellow Jalebi (Rajbhog) – Milk Labeling Error (2023)

Product label lists "butter" on the but does not include the common name for the allergen "milk"

Class IIModerate

FDAFeb 10, 2023TX• Rajbhog Distributors, Inc

Orange Jalebi (Rajbhog) – undeclared milk (2023)

Product label lists "butter" on the but does not include the common name for the allergen "milk"

Class IIModerate

FDAFeb 10, 2023TX• Rajbhog Distributors, Inc

Tacrolimus Capsules (Dr. Reddy's) - Incorrect Capsule Mix (2023)

Presence of Foreign Tablets/Capsules: Presence of one Tacrolimus 1 mg capsule co-mingled in a bottle containing and labeled as Tacrolimus 0.5 mg capsules.

Class IIModerate

FDAFeb 8, 2023Nationwide• Dr. Reddy's Laboratories, Inc.

ACL ELITE Analyzer (Instrumentation) – Test Definition Removal (2023)

Removes the test definition for HemosIL Liquid Anti-Xa (PN 0020302600 and 0020302601) from the ACL Elite/Elite Pro instruments

Low

FDAFeb 3, 2023Nationwide• Instrumentation Laboratory

ACL ELITE PRO-Analyzer (Instrumentation Laboratory) – Test Definition Removal (2023)

Removes the test definition for HemosIL Liquid Anti-Xa (PN 0020302600 and 0020302601) from the ACL Elite/Elite Pro instruments

Low

FDAFeb 3, 2023Nationwide• Instrumentation Laboratory

ACL ELITE Analyzer (Instrumentation) – Test Definition Removal (2023)

Removes the test definition for HemosIL Liquid Anti-Xa (PN 0020302600 and 0020302601) from the ACL Elite/Elite Pro instruments

Low

FDAFeb 3, 2023Nationwide• Instrumentation Laboratory

ACL ELITE PRO Analyzer (Instrumentation) – Test Definition Removal (2023)

Removes the test definition for HemosIL Liquid Anti-Xa (PN 0020302600 and 0020302601) from the ACL Elite/Elite Pro instruments

Low

FDAFeb 3, 2023Nationwide• Instrumentation Laboratory

CRP Immunoturbidimetric Reagent (Randox) – Antibody Bias (2023)

The Antibody (R2 reagent) is showing a positive bias compared to previous batches on patient samples. Quality Controls do not show the same bias and will be within range

Moderate

FDAFeb 1, 2023OH, PA, WV• Randox Laboratories

Honda Talon 1000 ROVs (Honda) - crash hazard (2023)

This recall expansion involves an additional 2,000 2021 model year Honda Talon 1000 side-by-sides with model numbers Talon 1000 S2 and Talon 1000 S4. The vehicles were sold in various colors including red, blue, green, gray and yellow. "HONDA" is printed on the front, sides and the rear of each vehicle. "Talon" is printed on a label located on both sides of the vehicle. The Vehicle Identification Number (VIN) number is stamped on the frame on the left side under the left front fender. The VIN range for affected Talon 1000s is as shown below. Original Recall: MY Model VIN Start VIN End 2019 Talon 1000 S2 1HFVE05**K4000003 1HFVE05**K4003902 2020 Talon 1000 S2 1HFVE05**L4100001 1HFVE05**L4102280 2021 Talon 1000 S2 1HFVE05**M4200001 1HFVE05**M4202760 2020 Talon 1000 S4 1HFVE06**L4000002 1HFVE06**L4003420 2021 Talon 1000 S4 1HFVE06**M4100001 1HFVE06**M4102218 Expanded Recall: : MY Model VIN Start VIN End 2019 Talon 1000 S2 1HFVE05**M4200084 1HFVE05**M4203061 2020 Talon 1000 S4 1HFVE06**M4100121 1HFVE06**M4102580

Moderate

CPSCJan 12, 2023Nationwide• American Honda Motor Co. Inc., of Torrance, California