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Abbott Molecular

Complete recall history across all FDA and CPSC categories — 6 total recalls

Abbott Molecular appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (6)

FDA medical device enforcement actions by Abbott Molecular

Date Product Reason Class
Oct 23, 2014 Abbott m2000sp, an automated system for performing sample preparation for nuc... Some versions of Application Specifications (App Spec) are incompatible with ... Class II
Jun 19, 2014 5 mL Reaction Vessels (a consumable of the Abbott m2000sp Automated Fluid Han... Abbott Molecular identified that some of the 5 ml Reaction Vessels (RVs) cont... Class II
Nov 23, 2013 The Abbott m2000sp is an automated system for performing sample preparation f... The x-drive assembly may fail prematurely. This could cause the manipulator ... Class II
Mar 28, 2013 The CEP 8 SpectrumGreen (SG) ASR Probe Kit, 20ul (list 06J37-018) is an Analy... 20 kits of CEP 8 SG ASR Probe (list 06J37-018, lot 440023), contained Vysis C... Class III
Dec 4, 2012 Abbott m2000sp Instrument; an automated fluid handling system for performing ... An issue with the m2000sp Instrument software has been identified whereby, af... Class II
Jan 31, 2012 Abbott Molecular Bar Code Scanner User's Guide; instructions for setting up t... In the Abbott Molecular Bar Code Scanner User's Guide, List Number 6L88-02/09... Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

Yes. You can search for any company using the firm/manufacturer pages for each category: Food Firms, Drug Firms, Device Firms, or Product Manufacturers. You can also use the search functionality on any browse page to find recalls by company name.

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