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).
FDA Recall Z-1238-2019 · Posted None
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Recalling FirmPerkinElmer Life and Analytical Sciences, Wallac, OY
Recall StatusOpen, Classified
Product CodeJHJ
Date Initiated2019-01-10
Product Quantity79 kits (none in US, all in ROW)
Reason for Recall
hCG analyte concentrations may be decreased up to 15- 20% at the lower measuring range of hCG concentrations.
Firm 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 use of the DELFIA / AutoDELFIA hCG kit lot and dispose the remaining kits of the lot.
Complete the Response Form with the quantity of affected DELFIA / AutoDELFIA hCG kits you have disposed from your inventory
Root Cause
Nonconforming Material/Component
Distribution Pattern
Worldwide distribution - US Nationwide distribution. and countries of Austria, Bolivia, UK, Switzerland,Thailand, Finland.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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