PerkinElmer Life and Analytical Sciences, Wallac, OY
Complete recall history across all FDA and CPSC categories — 9 total recalls
PerkinElmer Life and Analytical Sciences, Wallac, OY 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 (9)
FDA medical device enforcement actions by PerkinElmer Life and Analytical Sciences, Wallac, OY
| Date | Product | Reason | Class |
|---|---|---|---|
| Jan 10, 2019 | AutoDELFIA¿ hCG Kit, In Vitro Diagnostic for the determination of human gonad... | hCG analyte concentrations may be decreased up to 15- 20% at the lower measur... | Class II |
| Jan 10, 2019 | DELFIA¿ hCG Kit, In Vitro Diagnostic for the determination of human gonadotro... | hCG analyte concentrations may be decreased up to 15- 20% at the lower measur... | Class II |
| Jan 10, 2019 | AutoDELFIA¿ hCG Kit, In Vitro Diagnostic for the determination of human gonad... | hCG analyte concentrations may be decreased up to 15- 20% at the lower measur... | Class II |
| Nov 17, 2017 | Specimen Gate Screening Center, Part Number 5002-0500, All software versions ... | Potential errors in patient results generated by the Screening Center product... | Class II |
| Nov 2, 2017 | NeoBase Succinylacetone Assay Solution, Product Number: 3042-0020; Affected U... | There is a potential for leaking vials for certain lot numbers where, if prop... | Class II |
| Sep 25, 2017 | AutoDELFIA Neonatal immunoreactive trypsin(ogen) (IRT) kit, intended for the ... | The Quality Control Certificate for certain AutoDELFIA Neonatal IRT Kits is m... | Class III |
| Mar 7, 2017 | Specimen Gate Laboratory; Product Number: 5002-0180 Specimen Gate Laboratory... | Potential for errors in patient results generated by the Specimen Gate Labora... | Class II |
| Jan 5, 2017 | Genetic Screening Processor (GSP); PerkinElmer Part Number= 2021-0010 Inte... | The firm became aware that the ball bushing axels are defective in the GSP in... | Class II |
| Jan 5, 2017 | Spare Disk Remover Module; Product Number: 61001820 Intended for in vitro ... | The firm became aware that the ball bushing axels are defective in the GSP in... | 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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