PerkinElmer Health Sciences, Inc.
Complete recall history across all FDA and CPSC categories — 10 total recalls
PerkinElmer Health Sciences, Inc. 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 (10)
FDA medical device enforcement actions by PerkinElmer Health Sciences, Inc.
| Date | Product | Reason | Class |
|---|---|---|---|
| Dec 19, 2017 | PerkinElmer 226 Sample Collection Device | PerkinElmer 226 Sample Collection Devices Lot Number 40020001 had serial numb... | Class III |
| May 31, 2017 | PerkinElmer 226 Sample Collection Device The PerkinElmer 226 Sample Collec... | PerkinElmer 226 Sample Collection Devices Lot Number 317114 had serial number... | Class III |
| Dec 21, 2016 | AutoDELFIA¿ Plate Processor , Fluorometer, for clinical use Product Number:... | AutoDELFIA System with Version 3.0 Software: Potential plate loading failures | Class III |
| Dec 21, 2016 | DELFIA¿ PC with V3.0 Software, Fluorometer, for clinical use Product Number... | AutoDELFIA System with Version 3.0 Software: Potential plate loading failures | Class III |
| Dec 21, 2016 | Program Update Package AutoDELFIA¿ 3.0, Fluorometer, for clinical use Produc... | AutoDELFIA System with Version 3.0 Software: Potential plate loading failures | Class III |
| Dec 5, 2016 | EnLite Neonatal TREC Kit;an in vitro diagnostic device intended for the semi-... | Unique Device Identifier (UDI) is missing from outer kit box label. | Class III |
| Dec 1, 2016 | Specimen Gate Laboratory 5002-0180, Specimen Gate eReports 5002-0370, Softwar... | Issue may cause eReports to consume an excessive amount of disk space causing... | Class II |
| Nov 16, 2016 | DELFIA hFSH kit. In Vitro Diagnostic for the determination of hFSH in serum | A DELFIA hFSH kit lot failed real time stability testing. The real time stabi... | Class III |
| Jul 1, 2014 | Panthera-Puncher 9 . Panthera-Puncher 9 is a sample transfer instrument ... | Risk of incorrect results from samples prepared with Panthera-Puncher 9 | Class II |
| Jun 27, 2014 | PerkinElmer Specimen Gate Screening Center software, version 1.4 and 1.6; Pro... | Potential for demographic information and test result to be mismatch. | 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.
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