Recall Z-0924-2018— Wiener Laboratories

Name: FDA recall Z-0924-2018
Creator: U.S. Food and Drug Administration
Published: 2017-11-10

Class II · Ongoing

Class II FDA medical device recall by Wiener Laboratories, initiated 2017-11-10. It names one FDA 510(k) clearance: K023889. Product: Wiener Lab CHAGATEST ELISA RECOMBINANTE V. 3.0 Diagnosis of Chagas disease.. Reason: Internal program testing shows that product may not reach the indicated expiration date..

Recalling firm: Wiener Laboratories
Classification: Class II
Status: Ongoing
Initiated: 2017-11-10
Firm location: Riobamba, N/A, Argentina

510(k) clearances named in this recall

1 on FDA's record

K023889 — WIENER LAB. CHAGATEST ELISA RECOMNINANTE V.3.0, MODEL 96 TESTS CAT. NR. 1203254Wiener Laboratories Saic·cleared 2004-02-11

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

Wiener Lab CHAGATEST ELISA RECOMBINANTE V. 3.0 Diagnosis of Chagas disease.

Reason for recall

Internal program testing shows that product may not reach the indicated expiration date.

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