FDAJanuary 10, 2019device
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.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
hCG analyte concentrations may be decreased up to 15- 20% at the lower measuring range of hCG concentrations.
What to do
FDA enforcement status: Ongoing
Brands named
perkinelmer life and analytical sciences wallac oyperkinelmerperkinelmer life
UPCs
06438147009176
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAVOCSN+Pro package, REF: PRT-00853-000; VOCSN+Pro unit, REF: PRT-00490-0012026-05-08
- FDAVOCSN V+Pro package, REF: PRT-01198-000; VOCSN V+Pro unit, REF: PRT-01185-0002026-03-25
- FDATirzepatide Inj, 15mg x 4, Sterile Multi-Dose Vial, Rx only, Nomida, 25055 W Valley Pkwy, Suite 106, Olathe, KS 66061, NDC 84223-002-04.2026-02-26
- FDASemaglutide Inj., 2 mg x 5, Sterile Multi-Dose Vial, Rx only, Nomida, 25055 W Valley Pkwy, Suite 106, Olathe, KS 66061, NDC 84223-001-062026-02-26
- FDASemaglutide Inj, 2mg x 10, Sterile Multi-Dose Vial, Rx only, Nomida, 25055 W Valley Pkwy, Suite 106, Olathe, KS 66061, NDC 84223-001-07.2026-02-26
- FDATirzepatide Inj, 10mg, Sterile Multi-Dose Vial, Rx only, Nomida, 25055 W Valley Pkwy, Suite 106, Olathe, KS 66061, NDC 84223-002-03.2026-02-26
- FDAArtelon FlexBand Dynamic Matrix Ref: 310572026-02-06
- FDAArtelon FLEXBAND TWIST .12 Ref: TW012 3.85x17mm HEX Anchor (Qty 2) 5.0x17mm HEX Anchor (Qty 1) 0.5x12cm FLEXBAND (Qty 1)2026-02-06
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