Turku, N/A, Finland
PerkinElmer Life and Analytical Sciences, Wallac, OY recalls
4 recalls recorded since 2018, most recently on 10 January 2019. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls4
Ongoing (FDA)1
Terminated or completed3
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 10 January 2019
- Reason
- hCG analyte concentrations may be decreased up to 15- 20% at the lower measuring range of hCG concentrations.
- Distribution
- Worldwide distribution - US Nationwide distribution. and countries of Austria, Bolivia, UK, Switzerland,Thailand, Finland.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1239-2019, Z-1237-2019, Z-1238-2019
- AutoDELFIA¿ hCG Kit, In Vitro Diagnostic for the determination of human gonadotropin (hCG) Product Code: B007-112 - Product Usage: Quantitative determination of human gonadotrophin (hCG).
- DELFIA¿ hCG Kit, In Vitro Diagnostic for the determination of human gonadotropin (hCG) Product Code: A007-101 - Product Usage: Quantitative determination of human gonadotrophin (hCG) in serum.
- AutoDELFIA¿ hCG Kit, In Vitro Diagnostic for the determination of human gonadotropin (hCG) Product Code: B007-101 - Product Usage: Quantitative determination of human gonadotrophin (hCG).
Terminated Class II Medical devices
- Recall started
- 17 November 2017
- Terminated
- 12 August 2021
- Reason
- Potential errors in patient results generated by the Screening Center product that include both false negative and false positive results.
- Distribution
- Worldwide Distribution - US Distribution to the state of Georgia., and to the countries of : Belgium, Canada, Denmark, Italy, and United Kingdom.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1541-2018
- Specimen Gate Screening Center, Part Number 5002-0500, All software versions from 1.0 to 1.8 (current software version) Specimen Gate Screening Center is used for data management of neonatal screening test results and
Terminated Class II Medical devices
- Recall started
- 2 November 2017
- Terminated
- 17 September 2019
- Reason
- There is a potential for leaking vials for certain lot numbers where, if proper attire is not used as instructed, a transient minor allergic skin reaction may result when handling leaking succinylacetone reagent vials.
- Distribution
- Distributed in 20 US states: AL, AR, AZ, CA, CO, FL, GA, IL, IN, KS, KY, LA, MI, MO, NV, OH, OR, SC, TN, TX.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1692-2018
- NeoBase Succinylacetone Assay Solution, Product Number: 3042-0020; Affected UDI Numbers: (01)06438147295708(17)180531(10)654184 (01)06438147295708(17)180531(10)653414 (01)06438147295708(17)180531(10)653657 (01)0643814
Terminated Class III Medical devices
- Recall started
- 25 September 2017
- Terminated
- 6 September 2018
- Reason
- The Quality Control Certificate for certain AutoDELFIA Neonatal IRT Kits is missing information required to assess the acceptability of measured control values which may result in a delay in reporting IRT results.
- Distribution
- Distributed to CT and TX.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1220-2018
- AutoDELFIA Neonatal immunoreactive trypsin(ogen) (IRT) kit, intended for the quantitative determination of human immunoreactive trypsin(ogen) (IRT) in blood specimens. (UDI: (01)06438147298716(17)190430(10)656479); Produ
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.