Recall Z-2397-2019— Phadia Ab

Name: FDA recall Z-2397-2019
Creator: U.S. Food and Drug Administration
Published: 2019-07-09

Class II · Terminated

Class II FDA medical device recall by Phadia Ab, initiated 2019-07-09, terminated 2022-07-12. It names one FDA 510(k) clearance: K051218. Product: Phadia" 1000 Model # 12-3800-01 Product Usage: The instrument is fully integrated and automated instrument including software for immunodiagnostic testing. The instrument is designed to handle all steps from sample and reagent handling to processing of results.. Reason: code 7-102 Liquid Sensor Error.

Recalling firm: Phadia Ab
Classification: Class II
Status: Terminated
Initiated: 2019-07-09
Terminated: 2022-07-12
Firm location: Uppsala, N/A, Sweden

510(k) clearances named in this recall

1 on FDA's record

K051218 — MODIFICATION TO: UNICAP SPECIFIC IGEPharmacia Diagnostics AB·cleared 2005-06-09

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

Phadia" 1000 Model # 12-3800-01 Product Usage: The instrument is fully integrated and automated instrument including software for immunodiagnostic testing. The instrument is designed to handle all steps from sample and reagent handling to processing of results.

Reason for recall

code 7-102 Liquid Sensor Error

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