Z-1949-2019Class II

ColoCARE, Cat. No. 5650, packaged 250 envelopes/box, For In-Vitro Diagnostic Use. The firm name on the label...

Name: Z-1949-2019 ColoCARE, Cat. No. 5650, packaged 250 envelopes/box, For In-Vitro Diagnostic Use. The firm name on the label...
Creator: Helena Laboratories, Corp.
Published: 2018-08-08
License: https://open.fda.gov/license/

Helena Laboratories, Corp. / initiated 2018-08-08 / Open, Classified / root cause: manufacturing process

FDA source

Helena Laboratories, Corp. began a recall of ColoCARE, Cat. No. 5650, packaged 250 envelopes/box, For In-Vitro Diagnostic Use. The firm name on the label is Helena Laboratories, Beaumont, TX on 2018-08-08. FDA classified it as Class II and gives the reason as "The positive control on some tests of the lots did not appropriately react within the specified timeframe to verify the test was functioning correctly". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1949-2019
Classification: Class II
Status: Open, Classified
Initiated: 2018-08-08
Posted: 2019-07-05
Recalling firm: Helena Laboratories, Corp.
Product: ColoCARE, Cat. No. 5650, packaged 250 envelopes/box, For In-Vitro Diagnostic Use. The firm name on the label is Helena Laboratories, Beaumont, TX.
Product code: KHE Reagent, Occult Blood
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: The recalling firm made notifications beginning 8/8/2018 via phone and letter delivered via email. Customers were to dispose of the product.
Quantity in commerce: 27/250 pouch kits
Distribution: Distribution was made to AK, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, MI, MO, MS, MT, NC, ND, NE, NV, NY, OH, OK, PA, SD, TN, TX, VA, WA, and WY. There was no foreign/military/government distribution.
Product codes and lots: Kit lots 1-17-5650, exp. 8/31/2018, and 2-17-5650, exp. 9/30/2018. These kit lots contain ColoCARE pad lot numbers 1-17-551039, exp. 8/31/2018, and 2-17-551039, exp. 9/30/2018.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1949-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1949-2019	Class II	Ongoing	Voluntary: Firm initiated	2019-07-17	2019-07-05
Z-1950-2019	Class II	Ongoing	Voluntary: Firm initiated	2019-07-17	2019-07-05

Product code KHE

K882799Class IIHelena ColocareHelena Laboratories / cleared 1988-09-30

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)