Recall Z-1949-2019
Helena Laboratories, Corp. · initiated August 8, 2018
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / 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.
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.
FDA-determined cause: Nonconforming Material/Component
Action taken
The recalling firm made notifications beginning 8/8/2018 via phone and letter delivered via email. Customers were to dispose of the product.
Details
- Recall number
- Z-1949-2019
- Initiated
- August 8, 2018
- Product code
- KHE – Reagent, Occult Blood
- Quantity
- 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.
- Recalling firm
- Helena Laboratories, Corp., Beaumont, TX
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1950-2019 Class II | ColoCARE, Cat. No. 5651, packaged 50 envelopes/box, For In-Vitro Diagnostic Use. The…The positive control on some tests of the lots did not appropriately react within the specified timeframe to… | 08/08/2018Open, Classified |