Food, drugs, devices › PerkinElmer Life and Analytical Sciences, Wallac, OY
Device recall: Genetic Screening Processor (GSP); PerkinElmer Part Number= 2021-0010 Intended for in vitro quantitative and qualitative
PerkinElmer Life and Analytical Sciences, Wallac, OY (Turku, N/A) initiated this device recall on 5 Jan 2017; FDA lists 2 product records under event 76165, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 93% of the 1,091 device enforcement events initiated in 2017 carry the same class.
Status: Terminated, terminated 24 Aug 2017. Initiation: voluntary: firm initiated. PerkinElmer Life and Analytical Sciences, Wallac, OY has 6 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
PerkinElmer Life and Analytical Sciences, Wallac, OY, Turku, N/A, Finland.
Reason for recall
"The firm became aware that the ball bushing axels are defective in the GSP instrument. During exposure to humid conditions, there is a risk that the axle material will corrode. Deterioration of the axle can be observed as deposits of corrosion on the defective axles. Ball bushing axles may corrode and corrosion particle may cause contamination in the wells or the corrosion will cause movement…"
Distribution
"MA, SC, TX, AL OUS: China, Mexico, Peru, Morocco, Italy, Finland, Ecuador, Brazil"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1107-2017 | Genetic Screening Processor (GSP); PerkinElmer Part Number= 2021-0010 Intended for in vitro quantitative and qualitative determination of analytes in body fluids. | 24 instruments and 3 spare disk remover modules | Class II | Terminated | 8 Feb 2017 |
| Z-1108-2017 | Spare Disk Remover Module; Product Number: 61001820 Intended for in vitro quantitative and qualitative determination of analytes in body fluids. | 24 instruments and 3 spare disk remover modules | Class II | Terminated | 8 Feb 2017 |
Context
Other enforcement events for PerkinElmer Life and Analytical Sciences, Wallac, OY
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 10 Jan 2019 | DELFIA¿ hCG Kit, In Vitro Diagnostic for the determination of human gonadotropin (hCG) Product Code: A007-101 - Product | Device | Class II | 3 |
| 17 Nov 2017 | Specimen Gate Screening Center, Part Number 5002-0500, All software versions from 1.0 to 1.8 (current software version) | Device | Class II | 1 |
| 2 Nov 2017 | NeoBase Succinylacetone Assay Solution, Product Number: 3042-0020; Affected UDI Numbers: (01)06438147295708(17)180531(10 | Device | Class II | 1 |
| 25 Sep 2017 | AutoDELFIA Neonatal immunoreactive trypsin(ogen) (IRT) kit, intended for the quantitative determination of human immunor | Device | Class III | 1 |
| 7 Mar 2017 | Specimen Gate Laboratory; Product Number: 5002-0180 Specimen Gate Laboratory is intended for use as a data processing so | Device | Class II | 1 |
All 6 events for PerkinElmer Life and Analytical Sciences, Wallac, OY
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "The firm became aware that the ball bushing axels are defective in the GSP instrument. During exposure to humid conditions, there is a risk that the axle material will corrode. Deterioration of the axle can be observed as deposits of corrosion on the defective axles. Ball bushing axles may corrode and corrosion particle may cause contamination in the wells or the corrosion will cause movement…"
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "MA, SC, TX, AL OUS: China, Mexico, Peru, Morocco, Italy, Finland, Ecuador, Brazil"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 24 Aug 2017. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.