Recall Z-1950-2019— Helena Laboratories, Corp.

Name: FDA recall Z-1950-2019
Creator: U.S. Food and Drug Administration
Published: 2018-08-08

Class II · Ongoing

Class II FDA medical device recall by Helena Laboratories, Corp., initiated 2018-08-08. It names one FDA 510(k) clearance: K882799. Product: ColoCARE, Cat. No. 5651, packaged 50 envelopes/box, For In-Vitro Diagnostic Use. The firm name on the label is Helena Laboratories, Beaumont, TX.. Reason: The positive control on some tests of the lots did not appropriately react within the specified timeframe to verify the test was functioning correctly..

Recalling firm: Helena Laboratories, Corp.
Classification: Class II
Status: Ongoing
Initiated: 2018-08-08
Firm location: Beaumont, TX, United States

510(k) clearances named in this recall

1 on FDA's record

K882799 — HELENA COLOCAREHelena Laboratories·cleared 1988-09-30

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

ColoCARE, Cat. No. 5651, packaged 50 envelopes/box, For In-Vitro Diagnostic Use. The firm name on the label is Helena Laboratories, Beaumont, TX.

Reason for recall

The positive control on some tests of the lots did not appropriately react within the specified timeframe to verify the test was functioning correctly.

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