Recall Z-1237-2019— PerkinElmer Life and Analytical Sciences, Wallac, OY

Name: FDA recall Z-1237-2019
Creator: U.S. Food and Drug Administration
Published: 2019-01-10

Class II · Ongoing

Class II FDA medical device recall by PerkinElmer Life and Analytical Sciences, Wallac, OY, initiated 2019-01-10. It names one FDA 510(k) clearance: K862044. Product: 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.. Reason: hCG analyte concentrations may be decreased up to 15- 20% at the lower measuring range of hCG concentrations..

Recalling firm: PerkinElmer Life and Analytical Sciences, Wallac, OY
Classification: Class II
Status: Ongoing
Initiated: 2019-01-10
Firm location: Turku, N/A, Finland

510(k) clearances named in this recall

1 on FDA's record

K862044 — DELFIA (TM) HCG KITLkb Instruments, Inc.·cleared 1986-07-11

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

hCG analyte concentrations may be decreased up to 15- 20% at the lower measuring range of hCG concentrations.

Data sourced from openFDA. This site is unofficial and independent of the FDA.