Recall Z-1237-2019 ยท JHJ Agglutination Method, Human Chorionic Gonadotropin
PerkinElmer Life and Analytical Sciences, Wallac, OY
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.
| Date | Jan 10, 2019 |
| Status | Open, Classified |
| Reason | hCG analyte concentrations may be decreased up to 15- 20% at the lower measuring range of hCG concentrations. |
| Root cause | Nonconforming Material/Component |
| Action | Perkin Elmer initiated notification on January 10, 2018. The Recall Letter delivered to the end customer by email facilitated through the PerkinElmer Technical Support Group. PerkinElmer requires customers to: Inspect DELFIA / AutoDELFIA hCG kit inventory for the affected lots. Review your QC follow-up of the AutoDELFIA hCG assay for potential decrease in the control concentrations. If the control values are within your established acceptance range it is safe to report the results To avoid unnecessary repeat testing of samples, if the control values are out of the acceptance range discontinue |
| Quantity | 31 kits (10 in US, 21 in ROW) |
| Distribution | Worldwide distribution - US Nationwide distribution. and countries of Austria, Bolivia, UK, Switzerland,Thailand, Finland. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K862044 | DELFIA (TM) HCG KIT Lkb Instruments, Inc., Jul 11, 1986 |