Recall Z-0087-2022— Inpeco S.A.

Name: FDA recall Z-0087-2022
Creator: U.S. Food and Drug Administration
Published: 2021-09-10

Class II · Ongoing

Class II FDA medical device recall by Inpeco S.A., initiated 2021-09-10. It names one FDA 510(k) clearance: K121012. Product: FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2). (Different brand names of same product.). Reason: The Firmware (FW) of the Automation System Interface Module to ADVIA Centaur XP/XPT may lead to an incorrect association of test results to sample ID. Improper management of the sample may bring an incorrect patient result..

Recalling firm: Inpeco S.A.
Classification: Class II
Status: Ongoing
Initiated: 2021-09-10
Firm location: Lugano, N/A, Switzerland

510(k) clearances named in this recall

1 on FDA's record

K121012 — FLEXLAB 3.6, ACCELERATOR A3600Inpeco S.P.A.·cleared 2012-08-31

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

FlexLab (FLX), Accelerator a3600 (ACP), Aptio Automation (AP2). (Different brand names of same product.)

Reason for recall

The Firmware (FW) of the Automation System Interface Module to ADVIA Centaur XP/XPT may lead to an incorrect association of test results to sample ID. Improper management of the sample may bring an incorrect patient result.

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