The Recall Desk
HighFDA (Devices)·Z-1950-2019·Announced 2019-07-17

Helena Laboratories Recalls ColoCARE In-Vitro Diagnostic Kits

Helena Laboratories is recalling ColoCARE in-vitro diagnostic kits because the positive control failed to react appropriately in some tests.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a diagnostic device failure that could lead to inaccurate results, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Helena Laboratories, Corp. is recalling ColoCARE, Cat. No. 5651, in-vitro diagnostic kits. The recall involves 328/50-pouch kits distributed to laboratories in 34 states. The specific lots affected are 2-17-5651 (exp. 8/31/2018) and 3-17-5651 (exp. 9/30/2018), which contain ColoCARE pad lot numbers 1-17-551039 and 2-17-551039.

The recall was initiated because the positive control on some tests of the affected lots did not appropriately react within the specified timeframe. This failure prevents verification that the test was functioning correctly, which could lead to inaccurate diagnostic results.

The FDA has classified this as a Class II recall. Consumers and laboratories should stop using the affected kits and contact Helena Laboratories for instructions on return or replacement.

The recalled product

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.
Manufacturer
Helena Laboratories, Corp.
Category
Medical Device — In-Vitro Diagnostic
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (6)

  • Kit lots 2-17-5651
  • exp. 8/31/2018
  • and 3-17-5651
  • exp. 9/30/2018. These kit lots contain ColoCARE pad lot numbers 1-17-551039
  • and 2-17-551039
  • exp. 9/30/2018.

Distribution

Distributed in 34 states:

Part of a larger recall action

This product is one of 2 recalled by Helena Laboratories, Corp. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Related recalls

Same manufacturer · Helena Laboratories, Corp.

See all →

Same hazard · inaccurate diagnostic result

See all →