The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-1949-2019·Announced 2019-07-17

Helena Laboratories Recalls ColoCARE In-Vitro Diagnostic Kits

Helena Laboratories is recalling ColoCARE diagnostic kits because the positive control failed to react properly, potentially affecting test accuracy.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a functional defect in a diagnostic control that could lead to inaccurate results, but no specific patient injuries or illnesses are reported in the source text.

Plain-English summary

Helena Laboratories, Corp. is recalling specific lots of ColoCARE, Cat. No. 5650, which are packaged as 250 envelopes per box for in-vitro diagnostic use. The affected products include kit lots 1-17-5650 (exp. 8/31/2018) and 2-17-5650 (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 means the test may not have been functioning correctly, potentially leading to inaccurate diagnostic results.

Distribution of these kits was made to laboratories and facilities in 33 states, including 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, or government distribution. Users should stop using the affected lots and contact the manufacturer for instructions on return or replacement.

The recalled product

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.
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 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
  • 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 →

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